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 laboratory controls that include scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity [21 CFR 211.160(b)].** Specifically, your firm has not established laboratory controls that include appropriate final specifications for testing and release of AXIOFILL™ to assure that each batch conforms to appropriate standards of identity and purity during routine production.
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 1271.10(a)(1)
- 21 CFR 1271.3(d)
- 21 CFR 1271.3(f)(1)
- 21 CFR 210
- 21 CFR 211.100(a)
- 21 CFR 211.160(b)
- 21 CFR 211.110(a)(6)
- 21 CFR 211.160(b)(3)
- 21 CFR 211.84(d)(1)
- 21 CFR 211.84(a)
- 21 CFR 211.84(b)
- 21 CFR 312
- 21 CFR 600.3(r)