1Laboratory and QC controls
Laboratory Control Mechanisms are not established.
Inspection Record
Biocon Biologics Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Written sanitation and facility maintenance procedures are not established or followed.
3Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and make a record ofthe conclusions and follow-up.
4Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing or fully followed.
5Equipment and facility
Written procedures are not established or followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding ofa drug substance.
About this record
Extracted automatically from the document US FDA published on 2026-01-15. 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.
