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 receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a). Specifically, your firm's *Complaint Handling Procedure, Complaint RMA Procedure, Revision 01*, is inadequate and not fully implemented for the review, evaluation, and investigation of one hundred and seventy-seven plus (177+) complaints received involving the BlephEx Powered Eyelid Cleaning Sponge product. For example:
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 801.20(a)
- 21 CFR 801
- 21 CFR 803
- 21 CFR 806.10
- 21 CFR 806
- 21 CFR 807.81(a)
- 21 CFR 807.81(b)
- 21 CFR 820.22
- 21 CFR 820.30(i)
- 21 CFR 820.184
- 21 CFR 820.30(a)
- 21 CFR 820.25(b)
- 21 CFR 820.198(a)
- 21 CFR 820.198(a)(1)
- 21 CFR 820.198(a)(2)
- 21 CFR 820.198(b)
- 21 CFR 820.198(d)
- 21 CFR 820.198
- 21 CFR 820.100(a)
- 21 CFR 820.100(b)
- 21 CFR 820.100
- 21 CFR 820.30(a)(1)
- 21 CFR 820.50(a)
- 21 CFR 820.50(a)(2)
- 21 CFR 820
- 21 CFR 830
- 21 CFR 830.300(a)
- 21 CFR 830.3
- 21 CFR 878.4820
- 21 CFR 878.9
- 21 CFR 878.9(a)
- 21 CFR 886.4250
- 21 CFR 886.9(a)
- 21 CFR 886.4350
- 21 CFR 886.9(b)