Findings
1Equipment and facility
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment; and failed to perform operations within specifically defined areas of adequate size; and failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.67(b) and 21 CFR 211.42(c)). During our inspection, we observed inadequate cleaning and inadequate contamination control throughout your…
2Laboratory and QC controls
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). Your firm lacked appropriate spore population verification on in-house prepared biological…
3Aseptic processing and sterility assurance
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Your firm manufactures sterile drug products for (b)(4) , including (b)(4) , which are used (b)(4) . (b)(4) is also specifically labeled for use in (b)(4) . Your manufacturing process includes sterilizing the drug solution in sealed (b)(4) ampoules. Some…
About this record
Extracted automatically from the document US FDA published on 2026-05-05. 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.
