Findings
1Laboratory and QC controls
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)). Your firm manufactures…
2Stability and storage
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)). You lacked an adequate stability testing program for your drug products. For example, you lacked sufficient data to support the labeled expiry. You also lacked stability chambers to adequately store your stability samples. Further, the stability samples are not stored in the same container closure system in which…
3Quality unit oversight
Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, the QU failed to ensure: Establishment of an adequate cleaning and maintenance…
4Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). You failed to conduct adequate testing on incoming components, including an appropriate identity test of (b)(4) , a component at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination. Identity testing for (b)(4) , and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to…
About this record
Extracted automatically from the document US FDA published on 2025-10-28. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
