Findings
1Aseptic processing and sterility assurance
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). Your firm assigned a (b)(4) expiration date to your sterile (b)(4) despite having only (b)(4) of stability data. Additionally, your firm's procedure did not address ongoing stability testing to monitor your…
2Material and supplier control
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your firm relied solely on certificates of analysis (COAs) for incoming lots of (b)(4) , instead of conducting identity testing and verification for…
3Aseptic processing and sterility assurance
Your firm failed to conduct appropriate laboratory testing to determine whether each batch of drug product purporting to be sterile and pyrogen-free conforms to such requirements (21 CFR 211.167(a)). You manufactured and distributed an (b)(4) product labeled as "sterile." However, you failed to perform sterility testing. It is essential that you conduct sterility testing on these and other purportedly sterile drugs prior to batch disposition decisions. In response to this letter, provide a list of chemical and microbial test methods and specifications used to analyze each batch of your drug product before making a batch disposition decision, and the associated written procedures.
About this record
Extracted automatically from the document US FDA published on 2025-05-20. 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.
