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)).
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.128
- 21 CFR 207.77(c)
- 21 CFR 207.25(f)
- 21 CFR 207.41
- 21 CFR 211.113(b)
- 21 CFR 211.22
- 21 CFR 211.100(a)
- 21 CFR 211.84(d)(1)
- 21 CFR 211.167(a)
- 21 CFR 211.137(a)