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# Biocon Limited FDA-483
- URL: https://www.fdaweb.com/biocon-limited-fda-483/
- Published: 2020-03-11T12:00:00.000Z
- Updated: 2026-09-14T16:06:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146296

FDA has released the FDA-483 issued following a 1/20-1/24 inspection at Biocon Limited, an active pharmaceutical ingredient manufacturer in Karnataka, India. The five inspection observations on the [form](https://www.fda.gov/media/135890/download?ref=fdaweb.com) were: 

- failing to adequately perform cleaning validation protocols designed to assess potential product-to-product carryover in non-dedicated areas;
- failing to adequately investigate non-conformances;
- failing to adequately qualify equipment used in production operations;
- failing to fulfill the responsibilities of the quality control unit; and
- failing to adequately handle, store, and document material movement and status.