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 for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm has not established procedures for corrective and preventive action (CAPAs) and did not conduct any CAPAs. Your firm has also not established a system for the identification and input of quality data which may require corrective and/or preventive action.
Passage 2Failure to maintain device master records (DMR's) and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181. For example, your firm has not maintained Device Master Records (DMR’s) for its private label manufactured endoscopic medical devices intended for the U.S. market, including the Rigid Nasopharyngoscope.
Passage 3Failure to have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed, as required by 21 CFR 820.25(a). For example, your firm has not demonstrated it had any prior knowledge of U.S. FDA regulations and requirements including 21 CFR Part 820 - Quality System regulation.
Passage 4Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 803
- 21 CFR 803.17
- 21 CFR 806
- 21 CFR 807
- 21 CFR 820.181
- 21 CFR 820.184
- 21 CFR 820
- 21 CFR 820.198
- 21 CFR 820.160
- 21 CFR 820.186
- 21 CFR 820.30(a)
- 21 CFR 820.30
- 21 CFR 820.100(a)
- 21 CFR 820.100
- 21 CFR 820.198(a)
- 21 CFR 820.40
- 21 CFR 820.20
- 21 CFR 820.25(a)
- 21 CFR 820.25
- 21 CFR 830