# FDA 483 - Biocon Limited - March 05, 2019

Source: https://www.keypedia.com/records/483/biocon-limited/22848816-ba4b-4226-b8e4-859b1963ea4f

> FDA 483 for Biocon Limited on March 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Limited
- Inspection Date: 2019-03-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Biocon Limited, a non-sterile API manufacturer in Bangalore, India, revealed significant deficiencies across multiple areas. Observations included discrepancies between submitted drug master file information and actual manufacturing processes, inadequate bacterial endotoxin testing and environmental monitoring, and failures in laboratory controls regarding chromatographic data and equipment calibration. Additionally, the quality unit failed to investigate a critical process deviation.

## Related Officers

- [Anjali Shukla](https://www.keypedia.com/people/anjali-shukla/23e50484-91bf-436f-971e-2efd3c2b3d0a)
- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.keypedia.com/companies/biocon-limited/2da83be9-1e31-4fdf-af6b-4ad88608bebc

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1