Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure 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)].** For example, your finished product testing is limited to sterility testing and endotoxin testing as measurements of product attributes, and such testing does not demonstrate, for example, the identity and/or strength of your products.
Passage 2Failure to establish an adequate system for cleaning and disinfecting the room to produce aseptic conditions [21 CFR 211.42(c)(10)(v)].** Your cleaning validation is inadequate. For example, at the time of the inspection, you failed to validate the efficacy of the disinfectants used to clean and disinfect your cleanroom.
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 1271.3(d)
- 21 CFR 1271.15
- 21 CFR 1271.10(a)(2)
- 21 CFR 1271
- 21 CFR 1271.3(c)
- 21 CFR 1271.10(a)(1)
- 21 CFR 1271.10(a)(3)
- 21 CFR 210
- 21 CFR 211.113(b)
- 21 CFR 211.160(b)
- 21 CFR 211.192
- 21 CFR 211.42(c)(10)(iv)
- 21 CFR 211.42(c)(10)(v)
- 21 CFR 211.67(a)
- 21 CFR 312