FDA 483 - Biogenesis, Inc - February 27, 2025

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.