Inspection Record
View the regulator's official source The source document is always the basis for judgement.
There is a failure to thoroughly review any unexplained discrepancy, the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Drug products failing to meet established specifications are not rejected.
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, an d purity.
Equipment and utensils are not cleaned, maintained, sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product.
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established or followed.
Extracted automatically from the document US FDA published on 2024-08-06. 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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