1Aseptic processing and sterility assurance
Procedtu·es designed to prevent microbiological contalllillation ofdrug products ptupo1ti11g to be sterile are not followed.
Inspection Record
Lupin Limited Unit 2 — FDA 483 Findings
Inspectors Rafeeq A HabeebThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressm·e.
3Material and supplier control
Written procedm·es are not established and followed that describe the exanunations to be conducted on appropriate samples of iii-process materials of each batch.
4Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failm·e of a batch or any of its components to meet any ofits specifications whether or not the batch has been ah-eady distributed.
About this record
Extracted automatically from the document US FDA published on 2025-09-16. 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.
