1Material and supplier control
The identity of each raw material of drug substance is not verified by conducting at least one test to | verify the identity , using specific identity test.
Inspection Record
Aptuit Ltd — FDA 483 Findings
Inspectors Jose M. CayuelaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
Procedures designed to prevent microbiological contamination ofproducts purporting to be non-sterile | are not established.
3Laboratory and QC controls
The accuracy, sensitivity, specificity, reproducibility, and reliability of microbiological test methods has not been established.
4Quality unit oversight
The responsibilities applicable to the quality unit are not fully followed.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure to of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed .
6Material and supplier control
The amount of material taken from each container is not based upon appropriate criteria.
About this record
Extracted automatically from the document US FDA published on 2026-07-28. 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.
