1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products purpo1iing to be sterile did not include adequate validation of the aseptic process.
Inspection Record
Biocon Sdn. Bhd. — FDA 483 Findings
Inspectors Paranthaman Senthamarai KannanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Documentation and records
The batch production and conti·ol records are deficient in that they do not include documentation of the accomplishment ofeach significant step in manufacturing, processing, and packing.
3Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records are instituted by authorized personnel.
4Aseptic processing and sterility assurance
Procedmes designed to prevent microbiological contamination of diug products pmpo1iing to be sterile are not established, written or followed.
5Aseptic processing and sterility assurance
Aseptic processing areas ai·e deficient regai·ding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
6Deviation, CAPA, and investigation
There is a failure to review any unexplained discrepancy whether or not the batch has been ah-eady distributed.
7Other quality system
The responsibilities and procedures applicable to the quality conti·ol unit are not in writing and folly followed.
About this record
Extracted automatically from the document US FDA published on 2025-06-20. 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.
