Findings
1Deviation, 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). Your firm failed to open adequate investigations into out-of-specification (OOS) results. For example, (b)(4) batch (b)(4) failed initial testing due to unknown impurities. Your firm opened an out-of-specification investigation that included performing…
2Aseptic processing and sterility assurance
Your firm failed to 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)). Smoke studies demonstrated a lack of unidirectional airflow in your ISO 5 aseptic processing operation. Multiple instances of turbulent airflow in critical areas of ampoule filling line (b)(4) were noted, including during the…
3Laboratory and QC controls
Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). Your laboratory records lacked complete and original data to support the analyses performed. For example: A. During the inspection, we requested the testing worksheets from the (b)(4) studies you conducted on a compounding tank and its transfer line, which included endotoxin and…
4Aseptic 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)). You had inadequate procedures for monitoring of your (b)(4) gloves. Your procedures required sampling from (b)(4) glove on ampoule filling line (b)(4) at the conclusion of batch filling. In addition, your procedure lacked instructions that ensure all gloves are tested and specifying when they must be tested. In addition, your firm…
About this record
Extracted automatically from the document US FDA published on 2026-06-23. 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.
