1Laboratory and QC controls
The v.,ritten stability program for dmg products does not include reliable, meaningful and specific test methods.
Inspection Record
Lupin Limited — FDA 483 Findings
Inspectors Chad W Rice · Sandra A Boyd · Hung H DoThe 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
Procedures designed to prevent microbiological contamination ofdrug products pmpo,ting to be sterile are not established, written and followed.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
5Other quality system
There is a failure to thoroughly review any tu1explained discrepancy whether or not the batch has been already distributed.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products pmpo,ting to be sterile did not include adequate validation ofthe aseptic and sterilization process.
About this record
Extracted automatically from the document US FDA published on 2026-01-21. 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.
