# FDA 483 - Biocon Biologics Limited - Unknown Date

Source: https://www.keypedia.com/records/483/biocon-biologics-limited/fdee272a-ef56-45fc-8061-233169edfabf

> 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: Division of Advertising & Promotion 
- Summary: An FDA inspection of Biocon Limited in Bangalore, India, a drug product manufacturer, revealed significant deficiencies in their aseptic processing procedures and environmental monitoring. Observations included inadequate written procedures for preventing microbial contamination, poor aseptic techniques by operators, and ineffective investigations into environmental monitoring excursions. These issues indicate a lack of control over critical aspects of sterile drug product manufacturing.

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## Related Officers

- [Diane Raccasi, Microbiologist](https://www.keypedia.com/people/diane-raccasi-microbiologist/59492d65-0826-43ae-a353-e9843e8fe602)
- [Michael R. Shanks, Senior Biologist](https://www.keypedia.com/people/michael-r-shanks-senior-biologist/619295e6-cb39-4125-9a56-171774ce2cd5)

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