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# Biocon FDA-483 Released
- URL: https://www.fdaweb.com/biocon-fda-483-released-2/
- Published: 2018-03-13T12:00:00.000Z
- Updated: 2026-09-14T23:30:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140972

FDA has released the [FDA-483](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM600734.pdf?ref=fdaweb.com) issued following a 2/6-2/15 inspection at Biocon Sdn Bhd, a Johor, Malaysia, sterile drug manufacturer. The inspection observations were: 

- failing to establish or follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failing to thoroughly review any unexplained discrepancy to ensure that drug products conform to predetermined quality attributes;
- failing of an unexplained discrepancy to extend to other batches of the same drug product or other drug products that may be associated with the specific failure or discrepancy;
- failing to follow written production and process control procedures in execution of production and process control functions;
- failing of laboratory controls to include establishment of scientifically sound and appropriate test procedures designed to ensure that drug products conform to appropriate standards of identity, strength, quality, and purity;
- failing to have sufficient procedures for the cleaning and maintenance of equipment regarding inspection of the equipment for cleanliness immediately before use.