1Process validation
Written procedm·es are not established that desc1-ibe the in-process controls and exa,ninations to be conducted on approp,-iate samples ofin- process materials ofeach batch.
Inspection Record
Lupin Limited Unit-3 — 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
2Material and supplier control
Each component is not tested for confomuty with all appropriate w'l-itten specifications for ptu-ity, strength, and quality.
3Other quality system
There is a failure to thoroughly review any m1explained discrepancy whether or not the batch has been already distributed.
About this record
Extracted automatically from the document US FDA published on 2025-10-15. 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.
