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

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.