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 [21 CFR 211.42(c)(10)(iv)].** Your firm has not established an adequate system for environmental monitoring in the aseptic processing areas where your products are manufactured. For example:
Passage 2Failure to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR 211.100(a)].** For example, the manufacturing process for your product has not been validated.
Passage 3Failure to have an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions [21 CFR 211.42(c)(10)(v)].** For example, at the time of the inspection, you had not validated your process for cleaning and disinfecting the Biological Safety Cabinets (BSCs) and supporting cleanrooms where your product was manufactured.
Passage 4Failure to establish a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates [21 CFR 211.166(a)].** Specifically, you assigned a two-year expiration date to your product without supporting data.
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 1271.10(a)(1)
- 21 CFR 1271.3(d)
- 21 CFR 1271.3(f)(1)
- 21 CFR 1271.10(a)(2)
- 21 CFR 210
- 21 CFR 211.113(b)
- 21 CFR 211.42(c)(10)(iv)
- 21 CFR 211.160(b)
- 21 CFR 211.167(a)
- 21 CFR 211.100(a)
- 21 CFR 211.42(c)(10)(v)
- 21 CFR 211.166(a)
- 21 CFR 312