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 monitoring environmental conditions in aseptic processing areas to prevent contamination [21 CFR 211.42(c)(10)(iv)].** For example,
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1271.10(a)
- 21 CFR 1271
- 21 CFR 1271.15
- 21 CFR 1271.3(d)
- 21 CFR 1271.10(a)(1)
- 21 CFR 1271.3(f)(1)
- 21 CFR 1271.3(c)
- 21 CFR 1271.1
- 21 CFR 1271.20
- 21 CFR 210
- 21 CFR 211.42(c)(10)(iv)
- 21 CFR 211.42(c)(10)(v)
- 21 CFR 211.100(a)
- 21 CFR 211.160(b)
- 21 CFR 211.166(a)
- 21 CFR 211.113(b)