FDA 483 - MEDIPINES CORPORATION - January 22, 2024

An FDA inspection of MEDIFINES CORPORATION in Yorba Linda, CA, a manufacturer of the AGM 100 oximeter, revealed significant deficiencies in its quality system. The firm failed to adequately validate manufacturing processes, establish proper complaint handling procedures, and ensure the effectiveness of its corrective and preventive actions. These issues indicate a lack of control over critical aspects of medical device production and post-market surveillance.