1Other quality system
The use of instruments and apparatus not meeting established specifications was observed.
Inspection Record
Andrx Pharmaceuticals, Inc — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Control procedures are not established which validate the performance ofthose manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
3Quality unit oversight
The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
4Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch of any of its components to meet any of its specification whether or not the batch has been thoroughly distributed.
About this record
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.
