483
Seacole-CRC, LLCSeacole-CRC, LLC – FDA 483, Feb 13, 2026
Record Details
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.
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ID · 6d601161-e771-4f4c-a267-a209cadb81b0
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