FDA 483 - Seacole-CRC, LLC - February 13, 2026

An FDA inspection of Seacole-CRC, LLC in Plymouth, MN, revealed significant deficiencies in their quality management system and process validation. The firm failed to maintain adequate documentation for risk management, design transfer, sample testing, supplier control, and design changes. Additionally, procedures for validating manufacturing processes, including cleaning and liquid blending for medical devices, were not documented.