# Biocon Biologics Limited – FDA 483, Apr 29, 2026

Source: https://www.keypedia.com/records/483/biocon-biologics-limited/6015db2d-3565-46ce-9e68-1046c1e28414

> FDA 483 for Biocon Biologics Limited on April 29, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Biologics Limited
- Inspection Date: 2026-04-29
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Biocon Biologics Limited in Bengaluru, Karnataka, India, was cited for significant deficiencies during an FDA inspection of its drug substance and drug product manufacturing facility. The observations highlight severe issues with aseptic processing, including recurring microbial contamination and ineffective remediation efforts, as well as inadequate validation of aseptic and sterilization processes. Furthermore, the firm's quality system was found to be deficient in managing deviations, conducting timely investigations, and maintaining detailed batch records.

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## Related Officers

- [Yiwei Li](https://www.keypedia.com/people/yiwei-li/e5ea2c24-8e1e-43be-be23-e276b8848cff)
- [Sudipan Karmakar](https://www.keypedia.com/people/sudipan-karmakar/3037fa5f-a982-4b25-ad94-df1c9e81c853)
- [issuing_officer](https://www.keypedia.com/people/ying-xin-fan/905eacc9-1394-4215-9fbc-61c151c0debe)
- [Aniket Wadalkar](https://www.keypedia.com/people/aniket-wadalkar/d5019fb9-6309-4afa-aedc-b5e78ca3b93a)

Company: https://www.keypedia.com/companies/biocon-biologics-limited/7eb84509-8dc4-4765-9a0e-d2f65781328d

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4