Inspection Record
Inspectors Tamil Arasu · Saleem A AkhtarThe inspectors who signed the published document.Inspector lookup
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 and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been ah-eady distributed.
The accuracy, sensitivity, specificity and reproducibility oftest methods have not been established and documented.
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drng product.
Extracted automatically from the document US FDA published on 2025-03-06. 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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