FDA 483 - B-K Medical A/S - January 26, 2017

B-K Medical A/S, a medical device manufacturer in Herlev, Denmark, was inspected by the FDA from January 23-26, 2017. The inspection revealed significant deficiencies in the firm's complaint handling, medical device reporting (MDR) procedures, and personnel training documentation. These issues indicate a lack of adequate controls for managing product quality and safety concerns.