Findings
1Quality unit oversight
Your firm failed to establish written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)). You lacked an adequate quality unit (QU) to provide oversight for the manufacture of your drug products. For example, you did not review, approve, or implement procedures for critical quality operations such as handling non-conformances, change control, training management, and handling out-of-specification…
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. Your firm also failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination in light of its intended use…
3Stability and storage
Your firm failed to establish and follow a 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 failed to establish an adequate stability program with data demonstrating that the drug products remain acceptable throughout the labeled expiry date. For example, you assigned (b)(4) expiration dates to (b)(4)…
About this record
Extracted automatically from the document US FDA published on 2026-04-28. 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.
