# FDA 483 - Biocon Biosphere Limited - June 14, 2024

Source: https://www.keypedia.com/records/483/biocon-biosphere-limited/36d2a5cd-e8ac-4ec0-804c-57e8d74c80ef

> FDA 483 for Biocon Biosphere Limited on June 14, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Biosphere Limited
- Inspection Date: 2024-06-14
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Biocon Biosphere Limited in Visakhapatnam, India, revealed significant deficiencies across three observations. The firm failed to establish adequate written procedures for production and process controls, including the use of unqualified equipment and exceeding hold times for in-process materials. Additionally, laboratory controls were found to be lacking scientifically sound test procedures, indicating a potential impact on drug product quality.

## Related Documents

- [483 - 2024-06-14](https://www.keypedia.com/records/483/biocon-biosphere-limited/c43f95e9-c516-4fef-831a-147829ac5623)
- [483 - 2025-11-07](https://www.keypedia.com/records/483/biocon-biosphere-limited/303b1312-0294-4597-88e2-3746045dfd99)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)

Company: https://www.keypedia.com/companies/biocon-biosphere-limited/4c5f824e-c399-4c0e-91be-45739741dc2c

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