医療機器企業に対する483指摘の傾向 潟Cーコンプライアンス


医療機器企業に対する483指摘の傾向

査察、コンプライアンス、強制措置、刑事調査

2013年の査察による指摘サマリー (医療機器:1099件) 出典
2013年度は、CAPAに関する指摘(手順書+記録)だけで、46.5%を占める!!
これは、回収の増加する医療機器業界に対して、設計管理の充実を求めるものである。

Cite Id Ref No Frequency Short Description Long Description
3130 21 CFR 820.100(a) CAPA手順書 378
(34.4%)
Lack of or inadequate procedures Procedures for corrective and preventive action have not been [adequately] established. Specifically, ***
14713 21 CFR 820.198(a)
苦情ファイル
245
(22.3%)
Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established.  Specifically,***
3696 21 CFR 820.100(b)
CAPA記録
133
(12.1%)
Documentation Corrective and preventive action activities and/or results have not been [adequately] documented.  Specifically, ***
546 21 CFR 820.75(a)
プロセスバリデーション
127
(11.6%)
Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures.  Specifically, ***
630 21 CFR 803.17
MDR報告
124
(11.3%)
Lack of Written MDR Procedures Written MDR procedures have not been [developed] [maintained] [implemented].  Specifically, ***
479 21 CFR 820.50
購買管理手順書
110 Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established.  Specifically, ***
3282 21 CFR 820.90(a)
不適合品管理手順書
98 Nonconforming product,  Lack of or inadequate procedures Procedures have not been [adequately] established to control product that does not conform to specified requirements.  Specifically, ***
3103 21 CFR 820.30(i)
設計変更手順書
93 Design changes - Lack of or Inadequate Procedures Procedures for design change have not been [adequately] established.  Specifically,***
3331 21 CFR 820.181
DMR(製品標準書)管理
77 DMR - not or inadequately maintained A device master record has not been [adequately] maintained.  Specifically, ***
2327 21 CFR 820.22
内部監査手順書
73 Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been [adequately] established. Specifically, ***
14712 21 CFR 820.184
DHR(製造記録)管理
72 DHR - not or inadequately maintained A device history record has not been [adequately] maintained.  Specifically, ***
3125 21 CFR 820.80(d)
最終製品検査手順書
70 Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been [adequately] established. Specifically, ***
3172 21 CFR 820.198(c) 69 Investigation of device failures Complaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its specifications were not [reviewed] [evaluated] [investigated] where necessary. Specifically, ***
2350 21 CFR 820.25(b) 61 Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been [adequately] established. Specifically, ***
3101 21 CFR 820.30(g)
設計変更(設計の妥当性確認)
61 Design validation- Lack of or inadequate procedures Procedures for design validation have not been [adequately] established.  Specifically,***
3168 21 CFR 820.198(a) 58 Complaints Complaint files are not [adequately] maintained.  Specifically ***
14722 21 CFR 820.40 58 Procedures not adequately established or maintained Document control procedures have not been adequately [established] [maintained].  Specifically,***
3666 21 CFR 820.20(c) 57 Management review - Lack of or inadequate procedures Procedures for management review have not been [adequately] established.  Specifically,***
2371 21 CFR 820.30(a)
設計管理(総則)
55 Design control - no procedures Procedures for design control have not been established.  Specifically,***
3680 21 CFR 820.70(a) 54 Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been [adequately] established.   Specifically, ***
3160 21 CFR 820.184 53 Lack of or inadequate DHR procedures Procedures for device history records have not been [adequately] established.  Specifically,***
3678 21 CFR 820.30(g)
設計変更(設計の妥当性確認)
52 Design Validation - Risk analysis not performed/inadequate Risk analysis [was not performed] [is inadequate] [is incomplete].  Specifically, ***
3159 21 CFR 820.184 51 DHR content The device history record does not demonstrate that the device was manufactured in accordance with [the device master record] [21 CFR 820].
3233 21 CFR 820.72(a) 51 Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established.  Specifically, ***
3121 21 CFR 820.80(b) 46 Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been [adequately] established. Specifically, ***
541 21 CFR 820.70(c) 45 Environmental control  Lack of or inadequate procedures Procedures to control environmental conditions have not been [adequately] established.  Specifically, ***
732 21 CFR 803.50(a)(2) 43 Report of Malfunction An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.  Specifically, ***
3120 21 CFR 820.80(a) 41 Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been [adequately] established.  Specifically,***
3415 21 CFR 820.22 41 Quality Audit/Reaudit - conducted Quality [audits][reaudits] have not been performed.  Specifically, ***
3118 21 CFR 820.75(a) 39 Documentation Process validation [activities] [results] have not been  [documented] [approved] [adequately documented] [adequately approved].  Specifically, ***
3127 21 CFR 820.80(e) 38 Documentation Acceptance activities were not [documented] [maintained as part of the device history record] [adequately documented] [adequately maintained as part of the device history record].  Specifically, ***
3375 21 CFR 820.198(e) 38 Records of complaint investigation Records of complaint investigations do not include required information.  Specifically, ***
447 21 CFR 820.40 37 Lack of procedures, or not maintained Document control procedures have not been [established] [maintained].  Specifically,***
2650 21 CFR 820.30(f)
設計管理(設計検証)
37 Design verification - Lack of or inadequate procedures Procedures for design verification have not been [adequately] established.  Specifically,***
3104 21 CFR 820.30(j)
設計管理(DHF)
37 Design history file The design history file [was not established] [does not demonstrate that the design was developed following the approved design plan] [does not demonstrate that the design was developed following the requirements of 21 CFR 820].
3128 21 CFR 820.90(a) 36 Nonconforming product control Products that do not conform to specifications are not adequately controlled. Specifically, ***
4059 21 CFR 820.22 36 Quality Audits - defined intervals Quality audits were not performed [at defined intervals] [at sufficient frequency] to determine whether the quality system activities and results comply with quality system procedures.  Specifically, ***
2328 21 CFR 820.22 35 Quality audits - auditor independence Individuals who conduct quality audits have direct responsibility for the matters being audited. Specifically, ***
3669 21 CFR 820.20(c) 35 Management review - defined interval, sufficient frequency Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system [at defined intervals] [with sufficient frequency].  Specifically, ***
539 21 CFR 820.70(b) 32 Production and Process Change Procedures, lack of or Inad. Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately] established.  Specifically, ***
419 21 CFR 820.20(b) 30 Lack of or inadequate organizational structure The organizational structure has not been [adequately] established and maintained to ensure that devices are [designed] [produced] in accordance with 21 CFR 820.  Specifically, ***
537 21 CFR 820.70(a) 30 Production processes Production processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device conforms to its specifications.  Specifically, ***
3427 21 CFR 820.50(a)(2) 29 Supplier oversight The type and extent of control to be exercised over [the product] [services] [suppliers] [contractors] [consultants] was not clearly defined. Specifically, ***
2604 21 CFR 820.30(e)
設計管理(デザイン・レビュ)
28 Design review - Lack of or inadequate procedures Procedures for design review have not been [adequately] established.  Specifically,***
3117 21 CFR 820.70(i) 28 Software validation for automated processes Software used as part of [production] [the quality system] has not been [adequately] validated for its intended use according to an established protocol.  Specifically, ***
3837 21 CFR 820.25(b) 28 Training records Personnel training is not documented. Specifically, ***
486 21 CFR 820.50(a) 26 Evaluation of suppliers, contractors, etc., requirements Requirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately] established.   Specifically, ***
731 21 CFR 803.50(a)(1) 26 Report of Death or Serious Injury An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.  Specifically, ***
2968 21 CFR 812.100 26 Investigator non-compliance with agreement/plan/regulations An investigation was not conducted according to the [signed agreement] [investigational plan] [applicable FDA regulations].  Specifically, ***
2974 21 CFR 812.110(b) 26 Investigator non-compliance with agreement/plan/regulations An investigation was not conducted in accordance with [the signed agreement] [the investigational plan] [applicable FDA regulations] [conditions of approval imposed by an IRB] [conditions of approval imposed by FDA].  Specifically, ***
3123 21 CFR 820.80(c) 25 Lack of or inadequate In-process acceptance procedures Procedures for the [acceptance] [control] of in-process product have not been [adequately] established. Specifically, ***
3132 21 CFR 820.120 24 Lack of or inadequate procedures for labeling Procedures to control labeling activities have not been [adequately] established. Specifically, ***
3426 21 CFR 820.50(a)(1) 24 Documented evaluation The evaluation of potential [suppliers] [contractors] [consultants] was not documented.  Specifically, ***
14716 21 CFR 820.30(f)
設計管理(設計検証)
24 Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements.  Specifically, ***
14720 21 CFR 820.50(a)(3) 23 Acceptable supplier records, inadequate records Records of acceptable [suppliers] [contractors] [consultants] have not been [adequately] established.
3345 21 CFR 820.200(a) 22 Servicing - Lack of or inadequate procedures Procedures or instructions for [performing servicing activities] [verifying that servicing meets specified requirements] have not been [adequately] established. Specifically, ***
4191 21 CFR 806.10(a)(1) 22 Report of risk to health A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA.  Specifically, ***
2302 21 CFR 820.20(e) 21 Quality System Procedures Quality system procedures and instructions have not been established.  Specifically,***
3285 21 CFR 820.90(b)(2) 21 Product rework procedures, Lack of or inadequate procedures Procedures for rework of nonconforming product have not been [adequately] established.  Specifically, ***
631 21 CFR 803.17(a)(1) 20 Lack of System for Event Evaluations The written MDR Procedure does not include an internal system which provides for the timely and effective [identification] [communication] [evaluation] of events that may be subject to medical device reporting requirements.  Specifically, ***
2430 21 CFR 820.30(b)
設計管理(設計及び開発の計画)
20 Design plans - Lack of or  inadequate Design plans that describe or reference the design and development activities and define responsibility for implementation have not been [adequately] established.  Specifically, ***
2557 21 CFR 820.30(c)
設計管理(設計へのインプット)
20 Design input - documentation Design input requirements were not [adequately] documented.   Specifically, ***
3286 21 CFR 820.90(b)(1) 20 Procedures for product review,disposition lack of/inadequate Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been [adequately] established.  Specifically, ***
14710 21 CFR 820.150 20 Lack of or inadequate procedures for storage. Procedures for the control of storage areas and stock rooms have not been [adequately] established.  Specifically,***
3102 21 CFR 820.30(h)
設計管理(設計移管)
19 Design transfer - Lack of or inadequate procedures Procedures for design transfer have not been [adequately] established.  Specifically,***
3170 21 CFR 820.198(b) 18 Review and evaluation for investigation Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically, ***
3263 21 CFR 820.250(b) 18 Sampling plans Sampling plans are not [written][based on valid statistical rationale].  Specifically, ***
3201 21 CFR 820.40(a) 17 Not approved or obsolete document retrieval Documents that were [not approved] [obsolete] were observed at a location where they [could be] [are being] used. Specifically, ***
14505 21 CFR 812.140(a)(3) 16 Investigator's subject records inadequate Records of each subject's [case history] [exposure to the investigational device] are not all [accurate] [complete] [current].  Specifically, ***
3119 21 CFR 820.75(b) 15 Lack/Inad procedure-Monitoring/Control of Validated Proces Procedures for monitoring and control of process parameters for a validated process have not been [adequately] established. Specifically, ***
3226 21 CFR 820.70(g)(1) 15 Maintenance schedule, Lack of or inadequate schedule Schedules for the adjustment, cleaning, and other maintenance of equipment have not been [adequately] established.  Specifically, ***
3269 21 CFR 820.80(b) 15 Incoming acceptance records, documentation Acceptance or rejection of incoming product was not documented. Specifically, ***
632 21 CFR 803.17(a)(2) 14 Lack of System for Determining MDR Events The written MDR procedure does not include an internal system which provides for a standardized review process/procedure for determining when an event meets the criteria for reporting.  Specifically, ***
3108 21 CFR 820.70(e) 14 Contamination control, Lack of or inadequate procedures Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been [adequately] established.   Specifically, ***
3207 21 CFR 820.50(b) 14 Supplier notification of changes There is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product or service.  Specifically, ***
3671 21 CFR 820.25(a) 14 Personnel Personnel do not have the necessary [education] [background] [training] [experience] to perform their jobs. Specifically, ***
3262 21 CFR 820.250(a) 13 Statistical techniques - Lack of or inadequate procedures Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics have not been [adequately] established.  Specifically,***
3266 21 CFR 820.86 13 Acceptance status The acceptance status of product was not [identified to indicate conformance or nonconformance with acceptance criteria] [maintained].  Specifically, ***
3433 21 CFR 820.75(c) 13 Process changes - review, evaluation and revalidation A validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations occurred. Specifically, ***
4070 21 CFR 820.30(g)
設計変更(設計の妥当性確認)
13 Design validation - documentation The results of design validation, including [identification of the design] [method(s)] [the date] [the individual(s) performing validation], were not [adequately] documented in the design history file.  Specifically, ***
14714 21 CFR 820.30(c)
設計管理(設計へのインプット)
13 Design input - Lack of or inadequate procedures Procedures for design input have not been [adequately] established.  Specifically,***
3676 21 CFR 820.30(f)
設計管理(設計検証)
12 Design verification - documentation The design verification results, including [identification of the design] [method(s)] [the date] [the individual(s) performing the verification], were not [adequately] documented in the design history file.  Specifically, ***
454 21 CFR 820.40(a) 11 Document review, approval by designated individual Documents were  [not reviewed] [not approved] by designated individual(s) prior to issuance .  Specifically, ***
2984 21 CFR 812.140(a)(3)(i) 11 Investigator records of informed consent inadequate Records documenting that informed consent was obtained for each subject prior to participation in the study are not all [accurate] [complete] [current].  Specifically, ***
3313 21 CFR 820.120(d) 11 Records, DHR {see also 820.184(e)} Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR.  Specifically, ***
3425 21 CFR 820.50(a)(1) 11 Evaluation and Selection, Suppliers, Contractors, etc. Potential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to meet specified requirements.  Specifically, ***
3432 21 CFR 820.75(b)(2) 11 Documentation of validated process performance There is [no] [inadequate] documentation of [monitoring and control methods and data] [the date performed] [the individual performing the process] [the major equipment used] for a validated process. Specifically, ***
4189 21 CFR 820.198(a) 11 General Complaint handling procedures for [receiving] [reviewing] [evaluating] complaints have not been [established] [defined] [documented] [completed] [implemented].  Specifically, ***
14711 21 CFR 820.160(a) 11 Lack of or inadequate procedures for distribution Procedures for control and distribution of finished devices have not been [adequately] established.  Specifically,***
2293 21 CFR 820.20(d) 10 Quality plan A quality plan has not been [adequately] established.  Specifically, ***
3171 21 CFR 820.198(b) 10 Rationale documented for no investigation Records for complaints where no investigation was made do not include required information.  Specifically ***
3191 21 CFR 820.30(g)
設計変更(設計の妥当性確認)
10 Design validation - production units The design was not validated [under defined operating conditions] [using initial production units, lots or batches or their equivalents].  Specifically, ***
3192 21 CFR 820.30(g)
設計変更(設計の妥当性確認)
10 Design validation - user needs and intended uses Design validation did not ensure the device conforms to defined user needs and intended uses.  Specifically, ***
3199 21 CFR 820.40(a) 10 Document review, approval documentation The documentation of approval of documents does not include [the document approval date] [the signature of the approving official].  Specifically, ***
3204 21 CFR 820.40(b) 10 Change records, content Records of changes did not include [a description of the change] [identification of the affected documents] [the signature of the approving official(s)] [the approval date] [when the change became effective].  Specifically, ***
3231 21 CFR 820.70(i) 10 Documentation of software validation Software validation activities and results for computers or automated data processing systems used as part of [production] [the quality system] have not been [adequately] documented.   Specifically, ***
3235 21 CFR 820.72(a) 10 Equipment control activity documentation Equipment [calibrations] [inspections] [checks][maintenance activities] have not been documented.  Specifically, ***
3270 21 CFR 820.80(c) 10 Documentation In-process inspections, tests, or other verification activities and approvals were not documented. Specifically, ***
3683 21 CFR 820.70(g) 10 Equipment Installation, Placement, Specified Requirements The [appropriate design, construction, placement, and installation of manufacturing equipment have not been ensured] [equipment used in the manufacturing process does not meet specified requirements]. Specifically, ***
14715 21 CFR 820.30(d)
設計管理(設計からのアウトプット)
10 Design output - Lack of or inadequate procedures Procedures for design output have not been [adequately] established.  Specifically,***
812 21 CFR 803.56 9 Submission Within One Month A supplemental report was not submitted to FDA within one month following receipt of information that was not provided when the initial report was submitted.  Specifically, ***
2269 21 CFR 820.20(a) 9 Quality policy and objectives The [quality policy] [quality objectives] [was] [were] not established by management with executive responsibility.  Specifically, ***
2630 21 CFR 820.30(e)
設計管理(デザインレビュ)
9 Design review - documentation The design review results, including [identification of the design] [the date] [the individual(s) performing the review], were not documented in the design history file.  Specifically, ***
2981 21 CFR 812.140(a)(2)(i) 9 Investigator device accountability inadequate Records of [receipt] [use] [disposal] of a device that relate to the [type and quantity] [dates of receipt] [batch number or code mark] of the device are not all [accurate] [complete] [current].  Specifically, ***
3264 21 CFR 820.250(b) 9 Sampling methods - Lack of or inadequate procedures Procedures to ensure sampling methods are adequate for their intended use have not been [adequately] established.  Specifically,***
3668 21 CFR 820.20(c) 9 Management review dates The results and/or dates of management reviews are not documented. Specifically, ***
4212 21 CFR 806.20(b)(4) 9 Justification for not reporting A  justification for not reporting the correction or removal action to FDA that included [conclusions] [follow-ups] [reviews] by a designated person was not included in the record.  Specifically,***
502 21 CFR 820.60 8 Identification procedures, Lack of or inadequate procedures Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been [adequately] established.  Specifically, ***
633 21 CFR 803.17(a)(3) 8 Lack of  System for Timely Submission of Reports The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to [FDA] [manufacturers].  Specifically, ***
2970 21 CFR 812.100 8 Investigator lack of informed consent Informed consent was not obtained in accordance with the regulations regarding the protection of human subjects. Specifically, ***
3173 21 CFR 820.198(d) 8 Evaluation, timeliness, identification Complaints representing events that are MDR reportable were not [promptly reviewed, evaluated, and investigated by a designated individual] [maintained in a separate portion of the complaint files] [clearly identified]. Specifically, ***
3203 21 CFR 820.40(b) 8 Document change records, maintained. Records of changes to documents were not [adequately] maintained.  Specifically, ***
3206 21 CFR 820.50(b) 8 Approval, inadequate purchasing data Purchasing data that clearly describe or reference specified requirements for purchased or otherwise received product and services have not been [approved] [established] [adequately approved] [adequately established].  Specifically, ***
3232 21 CFR 820.72(a) 8 Equipment suitability & capability Certain [inspection] [measuring] [test] equipment is not [suitable for its intended purposes] [capable of producing valid results].  Specifically, ***
3677 21 CFR 820.30(g)
設計変更(設計の妥当性確認)
8 Design validation - software validation not performed Validation of device software [was not performed] [is inadequate] [is incomplete].  Specifically, ***
3686 21 CFR 820.90(b)(2) 8 Product rework documentation, DHR {see also 820.184} Rework and reevaluation activities have not been [fully] documented in the device history record.  Specifically, ***
14507 21 CFR 812.140(a)(3)(ii) 8 Investigator adverse effect records inadequate Records for each subject concerning [anticipated] [unanticipated] adverse device effects are not all [accurate] [complete] [current].  Specifically, ***
14718 21 CFR 820.30(g)
設計変更(設計の妥当性確認)
8 Design validation - Risk analysis Results of the design risk analysis were not [adequately] documented.  Specifically, ***
14719 21 CFR 820.30(h)
設計管理(設計移管)
8 Incorrect translation to production specifications The device design was not correctly translated into production specifications.  Specifically, ***
636 21 CFR 803.17(b)(2) 7 Reports and information documentation The written MDR procedure does not include documentation and recordkeeping requirements for all Medical Device Reports and information submitted to [FDA] [device manufacturers].  Specifically, ***
3139 21 CFR 820.140 7 Lack of or inadequate procedures for handling Procedures for product handling have not been [adequately] established.  Specifically,***
3149 21 CFR 820.180 7 Availability Required records [are not maintained at a location that is reasonably accessible to responsible officials of the manufacturer and to employees of the FDA] [were not made readily available for review and copying by the FDA] [are not legible] [are not stored to minimize deterioration and prevent loss] [are not backed up when stored in automated data processing systems].  Specifically, ***
3190 21 CFR 820.30(g)
設計変更(設計の妥当性確認)
7 Design validation acceptance criteria Acceptance criteria were not established prior to the performance of validation activities.  Specifically, ***
3237 21 CFR 820.72(b) 7 Remedial action When test/measurement equipment was found to not meet accuracy and precision limits, [no] [inadequate] action was taken to [bring the equipment into calibration] [evaluate whether there was any adverse effect on the device's quality].  Specifically, ***
3310 21 CFR 820.120(b) 7 DHR documentation of label release {see also 820.184} The DHR does not include [complete] records of examination and release of device labeling, including date and signature of the examiner.  Specifically, ***
3409 21 CFR 820.200(d) 7 Service reports Service reports [are not documented] [do not include the required information].  Specifically, ***
4057 21 CFR 820.20(a) 7 Management ensuring quality policy is understood Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization.  Specifically, ***
635 21 CFR 803.17(b)(1) 6 Info evaluated to determine if event was reportable The written MDR procedure does not include documentation and recordkeeping requirements for all information that was evaluated to determine if an event was reportable.  Specifically, ***
3138 21 CFR 820.130 6 Packaging Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution.  Specifically, ***
3147 21 CFR 820.170(a) 6 Lack of or inadequate instructions [Installation instructions] [inspection instructions] [test procedures] have not been [adequately] established.  Specifically,***
3236 21 CFR 820.72(b) 6 Calibration procedures - content Calibration procedures do not include [specific directions and limits for accuracy and precision] [provisions for remedial action].  Specifically, ***
14717 21 CFR 820.30(g)
設計変更(設計の妥当性確認)
6 Design validation - software validation documentation Results of the validation of the device software were not [adequately] documented.  Specifically, ***
733 21 CFR 803.50(b)(1) 5 Reporting Information Reasonably Known An MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer.  Specifically, ***
3346 21 CFR 820.200(b) 5 Analyzing service report Service reports were not analyzed following appropriate statistical methods. Specifically, ***
3434 21 CFR 820.75(c) 5 Documentation - review in response to changes or deviations There is no documentation of the [review and evaluation of a process] [revalidation of a process] performed in response to changes or process deviations.  Specifically, ***
3674 21 CFR 820.30(d)
設計管理(設計からのアウトプット)
5 Design output - documentation Design output was not [adequately] documented before release.  Specifically, ***
3841 21 CFR 820.90(b)(2) 5 Product rework adverse effects {see also 820.184} Documentation of rework and reevaluation activities does not include a determination of whether there has been any adverse effect from rework upon the product.  Specifically, ***
2431 21 CFR 820.30(b)
設計管理(設計及び開発の計画)
4 Design plans- updated Design plans were not [reviewed] [updated] [approved] as design and development evolves.  Specifically, ***
2648 21 CFR 820.30(f)
設計管理(設計検証)
4 Design verification procedures Procedures for verifying that design output meets design input were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
2985 21 CFR 812.140(a)(3)(ii) 4 Investigator records of relevant observations inadequate Records for each subject concerning [previous medical history] [condition upon entering the investigation] [condition during the course of the investigation] [all diagnostic test results] are not all [accurate] [complete] [current].  Specifically, ***
2994 21 CFR 812.140(b)(3) 4 Sponsor records of investigator agreements inadequate Signed investigator agreements that include the required financial disclosure information are not all [accurate] [complete] [current]. Specifically, ***
3064 21 CFR 812.140(a)(4) 4 Investigator protocol records inadequate Copies maintained of the study protocol are not all [accurate] [complete] [current].  Specifically, ***
3109 21 CFR 820.70(d) 4 Personnel requirements, Lack of or inadequate requirements Requirements have not been [adequately] established to address personnel [health] [cleanliness] [personal practices] [clothing].  Specifically, ***
3155 21 CFR 820.181(a) 4 DMR device specifications The device master record does not include or refer to the location of  device software specifications.  Specifically, ***
3239 21 CFR 820.72(b) 4 Remedial action - documentation Evaluations of out-of-calibration equipment and remedial actions taken were not documented. Specifically, ***
3309 21 CFR 820.120(b) 4 Examination for accuracy Labeling was not sufficiently examined by a designated individual for accuracy including [the correct expiration date] [control numbers] [storage instructions] [handling instructions] [certain additional processing instructions] before release.  Specifically, ***
3372 21 CFR 820.198(d) 4 Records of MDR Investigation Investigation records of MDR reportable complaints do not include required information.  Specifically ***
4192 21 CFR 806.10(a)(2) 4 Report of violation of the Act (see 803.52(e)(9)) A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.  Specifically, ***
14721 21 CFR 820.70(g)(2) 4 Periodic equipment inspections Periodic inspections of equipment [were not] conducted to ensure adherence to applicable maintenance schedules [were not documented].  Specifically, ***
2339 21 CFR 820.22 3 Quality Audit/Reaudit - documentation The dates of quality [audits][reaudits] have not been documented.  Specifically, ***
2628 21 CFR 820.30(e)
設計管理(デザイン・レビュ)
3 Design review procedures - personnel Procedures were not [established] [defined] [documented] [complete] [implemented] for ensuring that participants at each design review include [representatives of all functions concerned with the design stage being reviewed] [an individual who does not have direct responsibility for the design stage being reviewed] [any specialists needed].  Specifically, ***
2910 21 CFR 812.7(a) 3 Promotion or test marketing An investigational device was [promoted] [test marketed] prior to FDA approval/clearance.  Specifically, ***
2928 21 CFR 812.40 3 Sponsors' general responsibilities For an investigational study, [qualified investigators were not selected] [investigators were not provided with the information they need to conduct an investigation properly] [proper monitoring was not ensured] [IRB review and approval were not ensured] [an IDE application was not submitted to FDA for a significant risk study] [reviewing IRBs were not promptly informed of significant new information about an investigation] [FDA was not promptly informed of significant new information about an investigation].  Specifically, ***
2980 21 CFR 812.140(a)(1) 3 Investigator correspondence records inadequate Records relating to correspondence with [another investigator] [an IRB] [the sponsor] [a monitor] [FDA], including required reports, are not all [accurate] [complete] [current].  Specifically, ***
3007 21 CFR 812.140(d) 3 Record retention inadequate Required records were not all maintained [during the investigation] [for a period of two years after the date on which an investigation was terminated or completed] [for a period of two years after the date that the records were no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol].  Specifically, ***
3111 21 CFR 820.70(f) 3 Buildings Buildings [are not of suitable design] [do not contain sufficient space] to [perform necessary operations] [prevent mix-ups] [assure orderly handling of product].  Specifically, ***
3113 21 CFR 820.70(g) 3 Equipment design and installation Equipment used in the manufacturing process has not been appropriately [designed] [constructed] [placed] [installed] to facilitate maintenance, adjustment, cleaning, and use. Specifically, ***
3115 21 CFR 820.70(h) 3 Use and removal, Lack of or inadequate procedures Procedures for the use and removal of manufacturing material have not been [adequately] established.  Specifically, ***
3175 21 CFR 820.186 3 QSR The quality system record has not been [adequately] maintained   Specifically ***
3328 21 CFR 820.180(b) 3 Retention period Required records are not retained for [the design and expected life of the device] [at least 2 years from the date of release of the device for commercial distribution].  Specifically, ***
3332 21 CFR 820.184(e) 3 ID label, labeling The device history record does not include the primary identification label and labeling for each device.  Specifically, ***
14511 21 CFR 812.2(b) 3 Abbreviated requirements / non-significant risk study A clinical investigation that was determined to be a non-significant risk device study does not meet the abbreviated requirements for investigational device exemptions (IDEs).  Specifically, ***
14523 21 CFR 812.43(c) 3 No investigator agreement A signed investigator agreement was not obtained from each participating investigator .  Specifically,***
538 21 CFR 820.70(a) 2 Process control procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications were not [established] [defined] [documented] [implemented].  Specifically, ***
2338 21 CFR 820.22 2 Quality audit - audit report review Reports of results of quality [audits] [reaudits] are not reviewed by management having responsibility for the matters audited.   Specifically, ***
2602 21 CFR 820.30(d)
設計管理(設計からのアウトプット)
2 Design output - review and approval Design output was not [reviewed] [approved] before release.  Specifically, ***
2969 21 CFR 812.100 2 No investigator protection - subject rights, safety, welfare The rights, safety, and welfare of subjects in an investigational study were not [adequately] protected.  Specifically, ***
2973 21 CFR 812.110(a) 2 Subject participation prior to study approval Subjects were allowed to participate in an investigation prior to obtaining [IRB] [FDA] approval to conduct the investigation. Specifically, ***
2983 21 CFR 812.140(a)(2)(iii) 2 Investigator records of disposition of devices inadequate Records that relate to the [reason why devices] [quantity of devices that] were [returned to the sponsor] [repaired] [disposed of] are not all [accurate] [complete] [current]. Specifically, ***
2993 21 CFR 812.140(b)(2) 2 Sponsor device disposition records inadequate Records of disposition of a device which describe the batch number or code marks of any devices [returned to the sponsor] [repaired] [disposed of by the investigator or another person] and the reasons for and method of disposition reports are not all [accurate] [complete] [current].  Specifically, ***
3027 21 CFR 812.150(a)(4) 2 Investigator non-emergency safety or soundness changes In a non-emergency situation, [changes to] [deviations from] the investigational plan that could have affected [the scientific soundness of the plan] [the rights, safety, or welfare of human subjects] were initiated without prior approval of the changes from [the sponsor] [FDA] [the IRB] .  Specifically, ***
3048 21 CFR 812.150(b)(5) 2 Sponsor progress reports for non-significant risk study For an investigation subject to the abbreviated requirements, progress reports were not [always] submitted to all reviewing IRBs [at required intervals] [at least annually].  Specifically, ***
3049 21 CFR 812.150(b)(5) 2 Sponsor progress reports for significant risk study Progress reports for a significant risk device study were not submitted [at required intervals] [at least yearly] to [FDA] [all reviewing IRBs].  Specifically, ***
3065 21 CFR 812.140(a)(5) 2 Additional investigator records FDA requires Records that FDA requires by [regulation] [specific requirement] to be maintained for [a category of investigations] [a particular investigation] are not all [accurate] [complete] [current].  Specifically, ***
3193 21 CFR 820.30(g)
設計変更(設計の妥当性確認)
2 Design validation - simulated testing The design was not validated under actual or simulated use conditions.  Specifically, ***
3198 21 CFR 820.40(b) 2 Document changes, review and approval, communication Changes to documents were not [reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval] [communicated to appropriate personnel in a timely manner].  Specifically, ***
3200 21 CFR 820.40(a) 2 Document locations, Dissemination, etc. Documents were not available at all locations for which they are designated, used, or otherwise necessary.  Specifically, ***
3291 21 CFR 820.100(b) 2 Procedures The procedures addressing documentation of corrective and preventive action activities were not [established] [defined] [documented] [complete] [implemented].  Specifically, ***
3323 21 CFR 820.170(b) 2 Installer records The person installing the device did not [adequately] document the inspection and test results to demonstrate proper installation.
3343 21 CFR 820.198(e) 2 Maintained Records of complaint investigations are not maintained by the formally designated unit. Specifically, ***
3672 21 CFR 820.30(c)
設計管理(設計へのインプット)
2 Design input - review and approval Design input requirements were not [reviewed] [approved] by designated individual(s).  Specifically, ***
3692 21 CFR 820.100(a)(4) 2 CAPA verification/validation of corrective/preventive action Corrective and preventive actions have not been verified or validated to ensure that the action is effective and does not adversely affect the finished device.  Specifically, ***
7017 21 CFR 812.150(b)(7) 2 Sponsor final report for non-significant risk study For an investigation subject to the abbreviated requirements, a final report was not submitted to all reviewing IRBs [within six months] after [termination] [completion] of an investigational device study.  Specifically, **
621 21 CFR 803.11 1 Failure to use FDA Form 3500A An MDR adverse event report was submitted on a form other than FDA Form 3500A (MEDWATCH form) or an approved electronic equivalent.  Specifically, ***
638 21 CFR 803.17(b)(4) 1 Info which facilitates timely FDA follow-up The written MDR procedure does not include documentation and recordkeeping requirements for systems that ensure access to information that facilitates timely follow-up and inspection by FDA.  Specifically, ***
640 21 CFR 803.18(a) 1 Event files--failure to establish MDR event files have not been established and maintained.  Specifically, ***
642 21 CFR 803.18(b)(1)(i) 1 Adverse events--all info not in file MDR event files do not contain or reference all adverse event information in the possession of the reporting entity, including documentation of the deliberations and decision making process used to determine if an event was or was not reportable.  Specifically, ***
648 21 CFR 803.18(e) 1 MDR not  evaluated per 820.162 and 820.198 A submitted MDR event was not evaluated in accordance with the requirements of the regulations regarding [Failure Investigations] [Complaint Files].  Specifically, ***
649 21 CFR 803.18(e) 1 Info not obtained or submitted MDR files do not contain explanations of why required information [was not submitted] [could not be obtained].  Specifically, ***
658 21 CFR 803.30(a)(2) 1 Report of Serious Injury Within 10 Days The user facility did not submit FDA Form 3500A or electronic equivalent to the [known device manufacturer] [FDA, because the device manufacturer was unknown,] within 10 working days of becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of the facility.  Specifically, ***
735 21 CFR 803.50(b)(2) 1 Explanation of Incomplete Information An MDR report with incomplete information was submitted to FDA without a statement explaining why such information was incomplete and the steps taken to obtain the information.  Specifically, ***
745 21 CFR 803.52(b)(2) 1 Death An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block B that the outcome attributed to the adverse event was death.  Specifically, ***
793 21 CFR 803.53(a) 1 Firm Did Not Submit 5 Day Report A 5 day report was not submitted to FDA on Form 3500A within 5 workdays of becoming aware that a reportable MDR event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.  Specifically, ***
2913 21 CFR 812.7(b) 1 Commercialization An investigational device was commercialized by charging the [subjects] [investigators] a price larger than that necessary to recover costs of manufacture, research, development, and handling. Specifically, ***
2923 21 CFR 812.20(a)(1) 1 Did not submit IDE application to FDA An application was not submitted to FDA when [a significant risk device investigation was to be undertaken] [an investigation that involves exception from informed consent was intended] [FDA sent notification that an application was required for an investigation].  Specifically, ***
2930 21 CFR 812.42 1 Sponsor began study before IRB/FDA approval [An investigation] [Part of an investigation] was initiated before [FDA approval] [IRB approval]. Specifically, ***
2937 21 CFR 812.43(c)(1) 1 No curriculum vitae in investigator agreement The signed investigator agreements obtained from each participating investigator do not all include the investigator's curriculum vitae. Specifically, ***
2940 21 CFR 812.43(c)(4)(i) 1 No investigation agreement statement of commitment A signed agreement that includes a statement of the investigator's commitment to conduct an investigation in accordance with the [agreement] [investigational plan] [applicable FDA regulations] [conditions of approval imposed by the reviewing IRB] [conditions of approval imposed by the FDA] was not obtained from each participating investigator.  Specifically, ***
2966 21 CFR 812.66 1 No IRB notification of significant risk determination The reviewing IRB did not notify [the investigator] [the sponsor] after determining that a device study, presented for approval as a non-significant risk device study, was actually a significant risk device study.  Specifically, ***
2991 21 CFR 812.140(b)(1) 1 Sponsor correspondence records inadequate Records relating to correspondence with [another sponsor] [a monitor] [an investigator] [an IRB] [FDA], including required reports are not all [accurate] [complete] [current].  Specifically, ***
2995 21 CFR 812.140(b)(4) 1 Availability of records of non-significant risk studies For an investigation subject to the abbreviated requirements, records are not [consolidated in one location] [available for FDA inspection and copying].  Specifically, ***
2996 21 CFR 812.140(b)(4)(i) 1 Sponsor records re device use in non-significant risk study For an investigation subject to the abbreviated requirements, records which include the [name and intended use of the device] [objectives of the investigation] are not all [accurate] [complete] [current].  Specifically, ***
2999 21 CFR 812.140(b)(4)(iv) 1 Sponsor records of non-significant risk study IRBs For an investigation subject to the abbreviated requirements, records that include the name and address of each IRB that has reviewed the investigation are not all [accurate] [complete] [current].  Specifically, ***
3000 21 CFR 812.140(b)(4)(v) 1 Sponsor records re QSR/GMP & non-significant risk studies For an investigation subject to the abbreviated requirements, records that include a statement of the extent to which the regulations covering current good manufacturing practice would be followed in manufacturing the device reports are not all [accurate] [complete] [current]. Specifically, ***
3001 21 CFR 812.140(b)(4)(vi) 1 Sponsor lack of other FDA-required info For an investigation subject to the abbreviated requirements, records that include additional information required by FDA are not all [accurate] [complete] [current]. Specifically, ***
3003 21 CFR 812.140(b)(6) 1 Other sponsor records required by FDA inadequate Records that FDA requires to be maintained for [a category of investigation] [a particular investigation] are not all [accurate] [complete] [current].  Specifically, ***
3021 21 CFR 812.150(a)(1) 1 Investigator report of unanticipated adverse effects A complete and accurate report of an unanticipated adverse device effect was not prepared and submitted [within 10 working days after first learning of the effect] to [the sponsor] [the reviewing IRB].  Specifically, ***
3025 21 CFR 812.150(a)(3) 1 No investigator progress reports Progress reports on the investigation were not submitted [at the required intervals] [at least yearly] to the [sponsor] [monitor] [reviewing IRB]. Specifically, ***
3028 21 CFR 812.150(a)(4) 1 No approval for investigator change in non-emergency Prior approval was not obtained from the sponsor for [changes in] [deviations from] an investigational plan in a non-emergency situation.  Specifically, ***
3034 21 CFR 812.150(a)(6) 1 Investigator final report A final report to the [sponsor] [reviewing IRB] was not submitted [within three months] after [termination] [completion] of the investigation.  Specifically, ***
3038 21 CFR 812.150(b)(1) 1 Sponsor evaluation rpt not timely, distributed Reports of the results of evaluation of unanticipated adverse device effects were not all submitted [within 10 working days of receiving notice of the effect] to [FDA] [all reviewing IRBs] [all participating investigators].  Specifically, ***
3052 21 CFR 812.150(b)(6) 1 Sponsor notif. of rqst. to return/repair/dispose not made Notification was not sent to [FDA] [all reviewing IRBs] of a request that an investigator [return] [repair] [dispose of] any units of a device.  Specifically, ***
3054 21 CFR 812.150(b)(7) 1 30-day sponsor notification to FDA FDA was not notified [within 30 working days] of the [completion] [termination] of a significant risk device study.  Specifically, ***
3156 21 CFR 820.181(b) 1 DMR production process specifications The device master record does not include or refer to the location of [all] production and process specifications.  Specifically, ***
3167 21 CFR 820.198(a) 1 Complete files maintained Complete complaint files are not maintained.  Specifically, ***
3208 21 CFR 820.50(b) 1 Approval of purchasing data {see also 820.40(a)} The purchasing data were not approved.  Specifically, ***
3210 21 CFR 820.65 1 Documentation of control numbers {see also 820.184} Control numbers for [implantable or life supporting devices] [appropriate components] were not documented in the device history record.  Specifically, ***
3283 21 CFR 820.90(a) 1 Specific non-conforming product procedures Procedures for addressing the [identification] [documentation] [evaluation] [segregation] [disposition] [investigation] of nonconforming product were not [defined] [documented] [complete].  Specifically, ***
3347 21 CFR 820.200(c) 1 Service reports/MDRs/complaints Service reports that represent MDR reportable events were not automatically considered complaints and processed in accordance with the requirements of 21 CFR 820.198. Specifically, ***
3355 21 CFR 820.198(f) 1 Records accessibility Investigated complaints and records of investigation were not accessible to the manufacturing establishment.  Specifically, ***
3371 21 CFR 820.198(a)(3) 1 Processing MDRs {see also 803, 804} Complaint handling procedures have not been [established] [defined] [documented] [completed] [implemented] to ensure that all complaints are evaluated to determine whether the complaint should be filed as a Medical Device Report.  Specifically, ***
3378 21 CFR 820.198(e)(4) 1 Complainant data Records of complaint investigations do not include the [name] [address] [phone number] of the complainant.  Specifically, ***
3383 21 CFR 820.198(g) 1 Foreign complaint files The manufacturer's formally designated complaint unit is located outside of the United States and complaint records are not reasonably accessible in the United States.  Specifically, ***
3414 21 CFR 820.200(d)(6) 1 Test and inspection data Service reports do not include applicable test and/or inspection data.  Specifically, ***
3417 21 CFR 820.70(a)(2) 1 Production monitoring and control During production, [process parameters] [component and device characteristics] are not [fully] monitored and controlled.  Specifically, ***
3682 21 CFR 820.70(d) 1 Implementing Personnel Procedures, Health, Cleanliness. Requirements addressing the [health] [cleanliness] [personal practices] [clothing] of employees have not been implemented.  Specifically, ***
3688 21 CFR 820.100(a)(1) 1 Analysis of data/reports from data sources Not all [data] [reports] from quality data sources are analyzed to identify existing and potential causes of nonconforming product and other quality problems.  Specifically, ***
4201 21 CFR 806.10(c)(8) 1 Illness report Illnesses or injuries that have occurred with use of devices subject to corrections or removals have not been reported.  Specifically,***
4202 21 CFR 806.10(c)(9) 1 Device number, identification The [total number] [sub-lot identification] of devices subject to correction or removal actions was not reported.  Specifically,***
4204 21 CFR 806.10(c)(11) 1 Domestic & foreign consignees The [names] [addresses] [telephone numbers] of all domestic and foreign consignees of devices subject to correction or removal actions and number of devices distributed to each consignee were not reported.  Specifically,***
4207 21 CFR 806.10(d) 1 Notification of extended action No amended notification with required information was submitted within 10 working days of initiating an extension of the correction or removal action.  Specifically,***
4208 21 CFR 806.20(a) 1 Records not kept There is no record maintained of a correction or removal action that was not required to be reported to FDA.   Specifically,***
4210 21 CFR 806.20(b)(2) 1 Device model identification The records of devices subject to correction and removal actions did not contain the [model] [catalog] [code number] of the device and the manufacturing [lot] [serial number] [identifying number] of the device.  Specifically,***
4227 21 CFR 821.20(a) 1 Failure to track Devices identified in an FDA tracking order were not tracked in accordance with tracking procedures.  Specifically, ***
4252 21 CFR 821.25(c)(3) 1 Quality assurance procedures: 6-month & annual audits A quality assurance program that includes audit procedures for each device subject to tracking and audits performed at 6-month intervals for the first 3 years of distribution and annual audits thereafter using a statistically relevant sampling [has not been established] [is not complete] [has not been followed].  Specifically,***
4278 21 CFR 821.50(a) 1 Not available for inspection All device tracking records and all tracking information were not available for inspection.  Specifically,***
4430 21 CFR 803.18(d)(1) 1 Distributor responsibilities for records Device complaint records are not [established] [maintained] by the device distributor, including any relevant [incident information] [information regarding the evaluation of the allegations].  Specifically, ***
4436 21 CFR 803.40(a) 1 Report of death, injury by marketed device The importer failed to submit a report to FDA on FDA form 3500A, with a copy to the manufacturer, within 30 days after receiving  information that one of its marketed devices may have caused or contributed to a [death] [serious injury].  Specifically, ***
7006 21 CFR 812.43(c)(5) 1 No financial disclosure info in investigator agreement A signed agreement was not obtained from each participating investigator that includes [sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement] [a commitment to promptly update financial disclosure information if any relevant changes occur during the investigation and for one year following completion of the study].  Specifically, ***
7012 21 CFR 812.100 1 Investigator lack of control of investigational devices Devices under investigation were not properly controlled.  Specifically, ***
14508 21 CFR 812.140(a)(4) 1 Investigator record of protocol deviations inadequate Records showing [dates] [reasons for] each deviation from the protocol are not all [accurate] [complete] [current].  Specifically,***
14513 21 CFR 812.2(c)(3) 1 Needs IDE; diagnostic device exemption conditions not met An investigation requires an IDE, in that the device is a diagnostic device which [is invasive] [requires an invasive sampling procedure that presents significant risk] [by design or intention introduces energy into a subject] [is used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure].  Specifically, ***
14520 21 CFR 812.36(d) 1 No FDA approval for treatment IDE A treatment IDE did not have FDA approval.  Specifically, ***
14521 21 CFR 812.36(e) 1 No IRB approval for treatment use A treatment use study of an investigational device did not [comply with the regulations governing informed consent] [have IRB approval].  Specifically, ***
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