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 procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). Specifically, your firm has not established and does not maintain CAPA procedures for the initiation and implementation of corrective and preventive action, as required. In response to this Warning Letter, you should provide documentation of your CAPA procedures and details/strategy for initiating CAPAs for customer complaints.
Passage 2Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. Specifically, during the inspection, you affirmed to the investigator your firm has not established MDR procedures. During the inspection you committed to correcting this, however, FDA has not received any response from your firm.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 803.17
- 21 CFR 803
- 21 CFR 807.81(b)
- 21 CFR 807.3(d)
- 21 CFR 820.3(o)
- 21 CFR 820.198(a)
- 21 CFR 820.100(a)
- 21 CFR 820.30(a)
- 21 CFR 820
- 21 CFR 864.6550