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 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 211.84(d)(2)).
Passage 3Your firm did not adequately test your incoming component, **(b)(4)**, for identity prior to use in manufacturing. **(b)(4)** is a component that is at high risk for **(b)(4)** contamination. Your firm also accepted the **(b)(4)** raw material based on the supplier’s certificate of analysis (COA), without establishing the reliability of each of your component suppliers’ analyses at appropriate intervals. Additionally, the **(b)(4)** lot you utilized for drug product production had expired.
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 211.84(d)(1)
- 21 CFR 211.22
- 21 CFR 211.22(a)
- 21 CFR 211.22(d)
- 21 CFR 211.100(a)