1Material and supplier control
Samples from incoming raw materials should be collected from top, middle, bottom of the raw material containers to represent the entire content of the container.
Inspection Record
Lupin Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been thoroughly disb'ibuted.
3Other quality system
API Manufacturer Secondaiy reference standards should be appropriately prepared, identified, tested, approved, and stored.
4Process validation
Critical process parameters should be controlled and monitored during process validation studies.
About this record
Extracted automatically from the document US FDA published on 2020-02-04. 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.
