Findings
1Aseptic processing and sterility assurance
Failure to demonstrate that water used in the manufacture of your API is suitable for its intended use. Based on the records and information you provided, you failed to demonstrate that your (b)(4) water system is adequately monitored to ensure that it consistently produces water suitable for use in the manufacture of APIs intended for further processing into sterile drug products. Your (b)(4) water system must be adequately designed and properly maintained to minimize and…
2Stability and storage
Failure to design a documented, ongoing stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates. Based on the records and information you provided, your firm failed to perform routine stability testing to demonstrate that the quality attributes of your APIs remain acceptable throughout the labeled expiry period. For example, your firm did not provide sufficient…
3Laboratory and QC controls
Failure to validate and verify the suitability of analytical methods. Based on the records and information you provided, your firm failed to perform test method validation or verification for each test method used for drugs distributed to the United States. Test methods must be validated to show that they are suitable for their intended use or verified to show at least equivalence with United States Pharmacopeia (USP) compendial methods. Method validation and verification…
4Aseptic processing and sterility assurance
Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes. Based on the records and information you provided, your firm failed to conduct process validation for the (b)(4) APIs manufactured at your facility. These APIs are for use in further processing to produce sterile drug products and for pharmaceutical compounding operations. Process validation evaluates the soundness of design and state of…
About this record
Extracted automatically from the document US FDA published on 2026-05-19. 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.
