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 and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes [21 CFR 211.113(b)].** For example:
Passage 2Failure 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:
Passage 3Failure to establish written procedures for production and process control 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:
Passage 4Failure to thoroughly investigate any unexplained discrepancy, or 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].** For example, you failed to thoroughly investigate the following sterility and environmental monitoring failures:
Passage 5Failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates [21 CFR 211.166(a)].** Specifically, you assigned a **(b)(4)**- to **(b)(4)**-year expiration date to your products without stability testing.
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 1271.10(a)(2)
- 21 CFR 1271.3(d)
- 21 CFR 1271.15
- 21 CFR 1271.3(c)
- 21 CFR 210
- 21 CFR 211.113(b)
- 21 CFR 211.42(c)(10)(v)
- 21 CFR 211.160(b)
- 21 CFR 211.100(a)
- 21 CFR 211.192
- 21 CFR 211.166(a)
- 21 CFR 312