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)].
Passage 2Failure to have ceilings of smooth, hard surfaces that are easily cleanable in an aseptic processing area [21 CFR 211.42(c)(10)(i)].** Specifically, during the inspection, our investigators observed unused pieces of equipment, remnants of a surgical suite operated by a previous tenant of your facility, suspended from the ceiling of your cleanroom such that the ceiling and attached, unused equipment is not easily cleanable.
Passage 3Failure to establish and follow 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)-(b)].** Specifically:
Passage 4Failure 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)]**. For example, you failed to appropriately test or examine before release for use **(b)(4)** used in the manufacture of your products and the vials that contain the final product.
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)(1)
- 21 CFR 1271.3(f)(1)
- 21 CFR 210
- 21 CFR 211.113(b)
- 21 CFR 211.42(c)(10)(i)
- 21 CFR 211.160(b)
- 21 CFR 211.100(a)
- 21 CFR 211.84(a)
- 21 CFR 211.166(a)
- 21 CFR 312