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# Biocon Biosphere FDA-483
- URL: https://www.fdaweb.com/biocon-biosphere-fda-483/
- Published: 2024-07-24T12:00:00.000Z
- Updated: 2026-09-14T14:36:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157418

FDA has released the form FDA-483 issued following a 6/10-6/14 inspection at Biocon Biosphere, a drug manufacturing facility in Andhra Pradesh, India. The three inspection observations [were](https://www.fda.gov/media/180112/download?ref=fdaweb.com):

- failure to establish written procedures for production and process controls designed to assure that drug products have the identity, strength, purity, and quality that they are purported or represented to possess;
- in-process materials are not tested for identity, strength, quality, and purity and approved or rejected by the quality control unit after storage for long periods; and
- laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.