# FDA 483 - Biocon Limited - January 24, 2020

Source: https://www.keypedia.com/records/483/biocon-limited/0e542ee8-b1f0-4a06-b970-497310ad7d12

> FDA 483 for Biocon Limited on January 24, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Limited
- Inspection Date: 2020-01-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Biocon Limited, an Active Pharmaceutical Ingredients Manufacturer in Bommasandra Post, Bangalore, India, was cited for significant deficiencies during an FDA inspection. Observations included inadequate cleaning validation, insufficient investigation of non-conformances, poorly qualified production equipment, and failures in Quality Control Unit responsibilities. The firm also demonstrated inadequate material handling, storage, and documentation practices.

## Related Documents

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## Related Officers

- [Investigator](https://www.keypedia.com/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)

Company: https://www.keypedia.com/companies/biocon-limited/7b8920c7-f5be-4f17-8100-3bede3943790

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