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 thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
Passage 2Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
Passage 3Your firm failed to establish and follow required laboratory control mechanisms (21 CFR 211.160(a)).
Passage 4Your firm failed to have appropriate procedures for the integration of chromatographic peaks and for the review of chromatographic data processing.
Passage 5Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 210
- 21 CFR 211.192
- 21 CFR 211.100(a)
- 21 CFR 211.160(a)
- 21 CFR 211.188