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 establish adequate written production and control procedures for the charge-in of components designed to assure that the drug products produced have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.101).
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) and 211.84(d)(2)).
Passage 3You failed to conduct an adequate identity test on each shipment of each lot of components (including the ethanol active ingredient), used in the production of your drug products. You also failed to determine whether each component conformed with all appropriate written specifications for purity, strength, and quality before use.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.128
- 21 CFR 201.10(c)(4)
- 21 CFR 201.61(a)
- 21 CFR 210
- 21 CFR 211.101
- 21 CFR 211.188
- 21 CFR 211.84(d)(1)
- 21 CFR 211.22
- 21 CFR 211.165(a)
- 21 CFR 211.165(b)
- 21 CFR 211.137(a)
- 21 CFR 211.22(d)
- 21 CFR 330