# Kerry Inc. – FDA 483, Jul 14, 2026

Source: https://www.keypedia.com/records/483/kerry-inc/fc3c8887-6683-45a8-ac72-4caf2025c0cc

> FDA 483 for Kerry Inc. on July 14, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kerry Inc.
- Inspection Date: 2026-07-14
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Beatrix D. Hippe](https://www.keypedia.com/people/beatrix-d-hippe/4a5a5258-3099-46cd-9e56-2dce60668ac5)

Company: https://www.keypedia.com/companies/kerry-inc/c21f284b-8c8e-44ff-8732-ac984d684960

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d