Findings
1Stability and storage
Failure to perform holding of API under appropriate CGMP to avoid loss of API identity or purity. You did not adequately monitor your API storage conditions. For example, the temperature probes you used to monitor your controlled substances storage area and refrigerator were not operational at the time of FDA inspection. In addition, you did not monitor your storage areas for humidity. You were unable to provide records for temperature and humidity monitoring to demonstrate…
2Documentation and records
Failure to perform repackaging and relabeling of API under appropriate CGMP to avoid mix-ups and potential cross-contamination. Your firm performed repacking and relabeling operations of API in an uncontrolled and open environment without adequate controls to prevent mix-ups and cross-contamination. For example, you relabeled Dasatinib monohydrate API and repackaged sirolimus API without label issuance, line clearance procedures, and documentation such as a batch record…
3Complaint and recall handling
Failure to adequately investigate and document complaints or any unexplained discrepancies with the original API manufacturer. Your firm did not adequately investigate customer complaints for returned API. For example, you were made aware by (b)(4) that phentolamine mesylate API lot# (b)(4) was returned to your facility for “quality issues.” Nonetheless, you redistributed the same lot of API to a different customer without performing an adequate investigation to assess drug…
About this record
Extracted automatically from the document US FDA published on 2022-12-27. 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.
