Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1You failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.
Passage 2You failed to thoroughly investigate any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed (21 CFR 211.192).
Passage 3You 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)).
Passage 4You failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).
Passage 5You failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).
Passage 6You failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair (21 CFR 211.58).
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 200.10(b)
- 21 CFR 210
- 21 CFR 210.1(b)
- 21 CFR 211.22
- 21 CFR 211.192
- 21 CFR 211.113(b)
- 21 CFR 211.42(c)(10)(iv)
- 21 CFR 211.42(c)(10)(v)
- 21 CFR 211.58