1Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
Inspection Record
Lupin Limited — FDA 483 Findings
Inspectors Tamil ArasuThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
3Quality unit oversight
l'he responsibilities and procedures applicable to the quality control unit are not fully followed.
4Deviation, CAPA, and investigation
There is a failure to thoruughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
6Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed 10 assure that drug products conform to appropriate standards of identity.
About this record
Extracted automatically from the document US FDA published on 2026-02-18. 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.
