# FDA 483 - Biocon Limited - June 21, 2024

Source: https://www.globalkeysolutions.net/records/483/biocon-limited/9e2a687a-3f5a-490b-a0bf-5480556e84f1

> FDA 483 for Biocon Limited on June 21, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Limited
- Inspection Date: 2024-06-21
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: Biocon Limited, a manufacturer in Paravada, India, was cited for four observations during an FDA inspection. The findings include inadequate cleaning validation procedures, failure to review critical system alarms, insufficient temperature mapping for drug product storage, and deficiencies in microbial enumeration test method verification. These issues indicate a lack of robust quality control and adherence to GMP standards.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/biocon-limited/04ec7dc3-2fba-4501-9085-f0ef56c74bf5

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