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 adequate 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, as required by 21 CFR 211.100(a).** For example, your firm has not validated the manufacturing process for your product with respect to identity, strength, quality, and purity.
Passage 2Failure 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, as required by 21 CFR 211.113(b).** For example, your firm has not validated the aseptic process used to manufacture your product. Your product purports to be sterile and is expected to be sterile.
Passage 3Failure 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 already been distributed, as required by 21 CFR 211.192.** For example, between August 2023 and June 2025, **(b)(4)** lots of your finished product failed sterility testing. While you discarded these lots, you did not conduct investigations to determine the root cause(s) and whether other lots were impacted.
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
- 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 1271.1
- 21 CFR 1271.20
- 21 CFR 210
- 21 CFR 211.100(a)
- 21 CFR 211.113(b)
- 21 CFR 211.160(b)
- 21 CFR 211.192
- 21 CFR 211.42(c)(10)(v)
- 21 CFR 211.42(c)(10)(iv)
- 21 CFR 211.22(a)