FDA 483 - 21st Century Scientific Inc - September 17, 2021

An FDA inspection of 21st Century Scientific Inc, a medical device manufacturer in Coeur D'Alene, ID, revealed significant deficiencies in their quality management system. The firm failed to adequately control nonconforming products, establish proper purchasing and incoming product acceptance procedures, and maintain adequate training documentation. Additionally, the firm's COO was found to be auditing areas for which he had direct responsibility, compromising audit independence.