FDA 483 - Oscor Inc. - September 20, 2019

An FDA inspection of Oscor, Inc. in Palm Harbor, FL, revealed significant deficiencies in process validation and control procedures for medical device manufacturing. The firm failed to adequately validate critical processes like laser welding and adhesive drying, lacking scientific justification. Additionally, the inspection found that established process control procedures were not followed, including failures to report out-of-range energy readings and maintain proper documentation practices.