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 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 2You failed to adequately test your incoming **(b)(4)**, used as an active pharmaceutical ingredient, for **(b)(4)**. The use of **(b)(4)** contaminated with **(b)(4)** has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document *Policy for Testing of* **(b)(4)** to help you meet the CGMP requirements when manufacturing drugs containing **(b)(4)** at **(b)(4)
Passage 3Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
Passage 4Your firm failed to establish an adequate QU with the responsibilities and authority to oversee the manufacturing of drug products. For example, your QU failed to ensure:
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 210
- 21 CFR 211.84(d)(1)
- 21 CFR 211.194(a)
- 21 CFR 211.22
- 21 CFR 211.22(d)
- 21 CFR 211.160(b)
- 21 CFR 211.166(a)
- 21 CFR 211.180(e)