Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
Passage 2Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)).
Passage 3Your firm failed to establish a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
Passage 4Failure to promptly correct any violations may result in legal action without further notice including, without limitation, seizure and injunction.
Passage 5Failure to address violations of the FD&C Act may be cause for FDA to withhold approval of requests for export certificates and approval of pending new drug applications or supplements listing your facility as a supplier or manufacturer. We may re-inspect to verify that you have completed your corrective actions.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 101
- 21 CFR 101.5
- 21 CFR 101.36
- 21 CFR 101.9
- 21 CFR 101.36(b)(2)(iii)(E)
- 21 CFR 101.3(g)
- 21 CFR 101.9(c)
- 21 CFR 101.36(b)(2)(iii)(D)
- 21 CFR 201.10(c)(4)
- 21 CFR 201.128
- 21 CFR 201.66(b)
- 21 CFR 210.3(b)(7)
- 21 CFR 210.3(b)(8)
- 21 CFR 211.165(a)
- 21 CFR 211.84(d)(1)
- 21 CFR 211.166(a)
- 21 CFR 310.548(b)
- 21 CFR 310.548(a)
- 21 CFR 310.548
- 21 CFR 314.3(b)
- 21 CFR 330.1(e)
- 21 CFR 330