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 and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
Passage 2Your 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 3Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).
Passage 4Your firm failed to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (21 CFR 211.110(a)).
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 200.10(b)
- 21 CFR 201.115
- 21 CFR 210
- 21 CFR 210.1(b)
- 21 CFR 211.113(b)
- 21 CFR 211.192
- 21 CFR 211.42(c)(10)(iv)
- 21 CFR 211.110(a)