# FDA 483 - Biocon Biologics Limited - September 19, 2019

Source: https://www.keypedia.com/records/483/biocon-biologics-limited/81b17a36-3d2a-4a82-a70c-77f6fce4507a

> FDA 483 for Biocon Biologics Limited on September 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Biologics Limited
- Inspection Date: 2019-09-19
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: Biocon Biologics India Limited in Bangalore, India, was cited for significant deficiencies in its drug substance and drug product manufacturing operations. The inspection revealed incomplete root cause investigations for out-of-specification results, ineffective corrective actions for microbial excursions, and inadequate equipment qualification and maintenance programs. Furthermore, the firm demonstrated a lack of quality oversight, and its written procedures were either inadequate or not followed, leading to multiple batch rejections and a deficient pest control management system.

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## Related Officers

- [Scott Nichols, Ph.D., Microbiologist](https://www.keypedia.com/people/scott-nichols-phd-microbiologist/2b5696a8-21cc-4b58-8c90-9950f4c43849)
- [Richard Ledwidge, Ph.D., Biologist](https://www.keypedia.com/people/richard-ledwidge-phd-biologist/51161c1e-63da-4f24-bf8b-ecc1398c9dbe)
- [Steven Fong, Microbiologist](https://www.keypedia.com/people/steven-fong-microbiologist/58ea27ab-f7cd-4680-9253-7460c39911e5)

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

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0