Kerry Inc. – FDA 483, Jul 14, 2026
An FDA inspection of Kerry Biofunctional Ingredients Inc. in Rothschild, WI, an excipient manufacturer, revealed significant quality control failures. The firm released component materials confirmed to have E. coli without proper investigation, quarantine, or disposition. Additionally, the company failed to thoroughly investigate numerous out-of-specification microbiological results for incoming materials and lacked adequate procedures for compendial method updates, compromising analytical consistency.
- Person
ID · fc3c8887-6683-45a8-ac72-4caf2025c0cc
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.