Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). We observed multiple significant risks to product sterility during your aseptic manufacturing operations. Interventions Some interventions were not adequately designed to prevent the risk of contamination. For…
2Aseptic processing and sterility assurance
Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)). On February 11, 2025, we observed that tape was being used to secure (b)(4) to the interior ceiling of the (b)(4) filling line ISO 5 (Grade A) space. This tape was detached in multiple locations during the aseptic manufacture of (b)(4) injection, USP (b)(4) mg/mL ( (b)(4) mL), batch (b)(4) . Your decision to use tape in a critical area…
3Deviation, CAPA, and investigation
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). You failed to conduct adequate investigations. Investigations lacked data supporting the assigned root cause(s), were not adequately expanded to include all potentially affected drug products, or were not formally documented in your deviation system…
About this record
Extracted automatically from the document US FDA published on 2025-09-16. 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.
