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# 8 Observations in Biocon FDA-483
- URL: https://www.fdaweb.com/8-observations-in-biocon-fda-483/
- Published: 2024-10-08T12:00:00.000Z
- Updated: 2026-09-14T14:43:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157935

FDA has released the form FDA-483 issued following a 9/17-9/27 inspection at Biocon Sdn Bhd, a sterile drug product manufacturer in Johor, Malaysia. The eight inspection [observations](http://www.fda.gov/media/182539/download?ref=fdaweb.com) were:

- failure to establish or follow written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the aseptic process;
- failure to fully follow written responsibilities and procedures applicable to the quality control unit;
- failure to review any unexplained discrepancy whether or not the batch has been already distributed;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- failure to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess;
- the batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, and packing; and
- failure to exercise appropriate controls over computers or related systems to assure that changes in master production and control records are instituted by authorized personnel.