Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to have an adequate system for monitoring environmental conditions in an aseptic processing area necessary to prevent contamination or mixups [21 CFR 211.42(c)(10)(iv)].** Your firm has not established an adequate system for environmental, including personnel, monitoring in the aseptic processing areas where BioBurst Fluid and BioBurst Rejuv are manufactured. For example:
Passage 2Failure to withhold from use each lot of components, drug product containers, and closures until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit [21 CFR 211.84(a)].** Specifically, you told our investigator that components utilized within UCB (umbilical cord blood) manufacturing are not sampled and tested prior to being used in production.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1271
- 21 CFR 1271.10(a)
- 21 CFR 1271.15
- 21 CFR 1271.3(d)
- 21 CFR 1271.10(a)(2)
- 21 CFR 1271.3(c)
- 21 CFR 1271.10(a)(4)
- 21 CFR 1271.75(a)(1)
- 21 CFR 1271.75(d)(1)
- 21 CFR 1271.3(r)(2)
- 21 CFR 211.113(b)
- 21 CFR 211.42(c)(10)(iv)
- 21 CFR 211.84(a)
- 21 CFR 211.192
- 21 CFR 211.165(e)
- 21 CFR 312