Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
Passage 2Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
Passage 3Failure to establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution, as required by 21 CFR 820.160(a). For example:
Passage 4Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), including analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a).
Passage 5Failure to establish and maintain procedures for implementing corrective and preventive action, including verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).
Passage 6Failure to establish and maintain procedures for validating the device design, including risk analysis, where appropriate, as required by 21 CFR 820.30(g).
Passage 7Failure to establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities, as required by 21 CFR 820.80(a).
Passage 8Failure to submit any report required within 10 working days of initiating a correction or removal, as required by 21 CFR 806.10.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 803
- 21 CFR 803.52
- 21 CFR 803.12(a)
- 21 CFR 803.50(a)(2)
- 21 CFR 803.3
- 21 CFR 806
- 21 CFR 806.10
- 21 CFR 820.50
- 21 CFR 820.50(a)(1)
- 21 CFR 820.50(a)(2)
- 21 CFR 820.50(a)(3)
- 21 CFR 820.50(b)
- 21 CFR 820.198(a)
- 21 CFR 820.198(a)(1)
- 21 CFR 820.198(a)(3)
- 21 CFR 820.198(c)
- 21 CFR 820.160(a)
- 21 CFR 820.100(a)
- 21 CFR 820.100(a)(4)
- 21 CFR 820.30(g)
- 21 CFR 820.80(a)
- 21 CFR 892.2050