Inspection Record
Inspectors Michael H. TollonThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Laboratory controls do not include the establishment ofscientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards ofidentity, strength, quality and purity.
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laborator y testing.
Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfuctory cooforrnance to the final specifications and identity and strength ofeach active ingredient prior to release.
Extracted automatically from the document US FDA published on 2024-01-17. 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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