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# Biocon FDA-483 Released
- URL: https://www.fdaweb.com/biocon-fda-483-released/
- Published: 2020-04-02T12:00:00.000Z
- Updated: 2026-09-14T16:09:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146488

FDA has released the FDA-483 issued following a 2/10-2/21 inspection at Biocon Sdn Bhd, a biotech firm in Johor, Malaysia. The three inspection observations were: 

- failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed;
- failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; and
- failing to maintain in writing and fully follow responsibilities and procedures applicable to the quality control unit.