# FDA 483 - Biocon Biologics Limited - Unknown Date

Source: https://www.keypedia.com/records/483/biocon-biologics-limited/2c321b5f-38d2-45ab-b9a4-83ed47b8fcb3

> FDA 483 for Biocon Biologics Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Biologics Limited
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Biocon Biologics Limited, a drug substance manufacturer in Electronics City Bengaluru, India, was cited for significant deficiencies across its facilities, equipment, quality control, and laboratory systems. Observations included inadequate sanitation and equipment maintenance, failure to thoroughly investigate out-of-specification results and system integrity, and lack of established laboratory control mechanisms. These issues indicate a systemic breakdown in maintaining a state of control and ensuring product quality.

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- [483 - 2022-08-26](https://www.keypedia.com/records/483/biocon-biologics-limited/2a485423-2dfe-4c01-a453-37bac55a142b)
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- [483 - Unknown Date](https://www.keypedia.com/records/483/biocon-biologics-limited/a47b55c7-311b-402e-9508-ef9684437834)

## Related Officers

- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.keypedia.com/companies/biocon-biologics-limited/d4e5402d-7d48-48ee-911b-8a78bfb97a67

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