# FDA 483 - Bell Pharmaceuticals, Inc - June 18, 2025

Source: https://www.keypedia.com/records/483/bell-pharmaceuticals-inc/ca17d9b1-2899-494f-aa5c-fc1b265b1f79

> FDA 483 for Bell Pharmaceuticals, Inc on June 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bell Pharmaceuticals, Inc
- Inspection Date: 2025-06-18
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Bell Pharmaceuticals, Inc. in Belle Plaine, MN, was inspected and cited for significant deficiencies across its manufacturing and quality control operations. The inspection revealed a lack of adequate procedures for change management, ineffective corrective actions, and insufficient laboratory controls for product testing and water monitoring. Additionally, issues were noted with equipment qualification, yield calculations, and electronic data integrity.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)

Company: https://www.keypedia.com/companies/bell-pharmaceuticals-inc/bb92f552-7a5a-4a84-b282-4310321b816b

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