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# Biocon FDA-483
- URL: https://www.fdaweb.com/biocon-fda-483/
- Published: 2019-03-12T12:00:00.000Z
- Updated: 2026-09-15T01:11:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143588

FDA has released the FDA-483 issued following a 2/7-2/15 inspection at Biocon Limited, a Bangalore, India, drug product manufacturer. The two inspection observations were: 

- procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, adequately validated, and/or followed; and
- written records of investigations into unexplained discrepancies do not always include an adequate conclusion and follow-up.