# FDA 483 - Biogenesis, Inc - February 27, 2025

Source: https://www.keypedia.com/records/483/biogenesis-inc/1c2a5a5a-c07f-4e44-bd2a-c8607e8fe6a2

> FDA 483 for Biogenesis, Inc on February 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biogenesis, Inc
- Inspection Date: 2025-02-27
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Biogenesis, Inc. in Paterson, NJ, an OTC drug manufacturer, received an FDA Form 483 with one observation. The inspection found that equipment was not cleaned at appropriate intervals, specifically noting white powder residue on a kettle labeled as "Clean" that is used for manufacturing various OTC drug products. This condition indicates a potential risk of contamination to drug products.

## Related Officers

- [Amatul H. Marium](https://www.keypedia.com/people/amatul-h-marium/5db400ce-ffde-4310-82f8-766fd2458a4d)
- [Raihan A. Chowdhury](https://www.keypedia.com/people/raihan-a-chowdhury/739813d5-2f9b-4048-91c7-911fd595f8d3)

Company: https://www.keypedia.com/companies/biogenesis-inc/847a28b3-ca74-493b-a09f-eedbdfa0c5fc

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248