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# 7 Inspection Observations at Biocon Limited
- URL: https://www.fdaweb.com/7-inspection-observations-at-biocon-limited/
- Published: 2018-05-02T12:00:00.000Z
- Updated: 2026-09-15T00:02:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141352

FDA has completed a pre-approval inspection of the Biocon sterile drug manufacturing facility in Bangalore, India, and issued an FDA-483 with seven inspection observations. In a [filing](https://www.bseindia.com/xml-data/corpfiling/AttachLive/fb7dd1fb-0b4d-4192-9be8-d307e9a5a6d9.pdf?ref=fdaweb.com) with the National Stock Exchange of India, Biocon says the inspection observations “are largely procedural and aimed at continuous improvement.” It says it will respond to FDA with a timely corrective and preventive action plan.