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 test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1).
Passage 3Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).
Passage 4You failed to provide adequate stability data to demonstrate that the chemical properties of your drug products remain acceptable throughout the labeled expiry period.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.66(b)(2)
- 21 CFR 201.128
- 21 CFR 210
- 21 CFR 211.165(a)
- 21 CFR 211.84(d)(1)
- 21 CFR 211.137(a)
- 21 CFR 330