Biosearch Medical Products, Inc. – FDA 483, Oct 11, 2022

An FDA inspection of Biosearch Medical Products, Inc. in Concord, NC, a manufacturer of medical device coatings, revealed significant deficiencies in their quality system. The firm failed to establish and maintain critical procedures for process validation, supplier evaluation, incoming product acceptance, device master records, device history records, and quality audits. These issues indicate a lack of fundamental controls necessary for ensuring product quality and regulatory compliance.