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 an adequate system for preventing contamination and monitoring environmental conditions in aseptic processing areas. [21 CFR 211.42(c)(10)(iv)]. Your firm also failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. [21 CFR 211.113(b)].** For example,
Passage 2Your firm failed to establish 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)].** For example, there was no procedure for 100% visual inspection of the final drug product to ensure that it is essentially free from visible particulates, which is necessary to ensure quality and purity prior to intravascular administration.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 210
- 21 CFR 211.56(a)
- 21 CFR 211.42(c)(10)(iv)
- 21 CFR 211.113(b)
- 21 CFR 211.42(c)(10)(v)
- 21 CFR 211.100(a)
- 21 CFR 211.192
- 21 CFR 312.21(b)