Inspection Record
Inspectors Julia N Alvarez · Christina K Theodorou · Juanita P Versace and 1 moreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Repo1is ofanalysis from component suppliers are accepted in lieu oftesting each component for conformity with all appropriate written specifications, without establishing the reliability ofthe supplier's analyses through appropriate validation ofthe supplier's test results at appropriate intervals.
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been aheady distributed.
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
The quality control unit lacks the responsibility and authority to approve all components and drng products.
Extracted automatically from the document US FDA published on 2025-02-12. 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.
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