FDA 483 - BK Medical Holding Company - May 27, 2022

BK Medical Holding Company, an initial importer based in Burlington, MA, was inspected by the FDA from May 25 to May 27, 2022. The inspection resulted in a Form FDA 483, citing critical observations regarding the company's quality system, under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. Key violations included the inadequate establishment of complaint handling procedures; specifically, 11 complaint files were processed before the firm's formal complaint procedure was even in place. Furthermore, the company lacked any established procedures for implementing corrective and preventive actions (CAPA), a fundamental aspect of quality management. Lastly, there were no established procedures for training or identifying training needs, evidenced by employees processing complaints months before receiving the necessary training. While the FDA 483 itself outlines observations rather than explicit required actions, BK Medical is responsible for thoroughly addressing these deficiencies by establishing and implementing robust procedures for complaint management, CAPA, and employee training to ensure full regulatory compliance.