# FDA 483 - Biocon Biologics Limited - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/biocon-biologics-limited/a47b55c7-311b-402e-9508-ef9684437834

> 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 Partnerships
- Summary: An FDA inspection of Biocon Biologics Limited in Electronics City Bengaluru, India, revealed significant deficiencies across multiple systems. The firm failed to establish and follow adequate procedures for facility maintenance, equipment cleaning, and quality control investigations. These issues included unsanitary manufacturing areas, rusted equipment, insufficient investigation into microbial contamination, and a lack of proper documentation for equipment repairs and laboratory errors, indicating a systemic breakdown in GMP compliance.

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## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3