483
Biogenesis, IncBiogenesis, Inc – FDA 483, Feb 27, 2025
Record Details
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.
View Company Profile
ID · 1c2a5a5a-c07f-4e44-bd2a-c8607e8fe6a2
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.