FDA 483 - BM Korea Co. Ltd. - February 27, 2020

BM KOREA CO., LTD., a medical device manufacturer in Gunpo, Gyeonggi, Korea, received a Form FDA 483 with seven observations during an inspection. The firm demonstrated significant deficiencies across its quality system, including inadequate procedures for document control, complaint handling, nonconforming product, environmental conditions, design review, and device history records. Additionally, the company lacked an established quality policy from executive management.