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

BK Medical Holding Company, an initial importer in Burlington, MA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked adequately established procedures for receiving, reviewing, and evaluating complaints, as well as for implementing corrective and preventive actions. Additionally, procedures for training and identifying training needs were not established, leading to employees processing complaints before receiving proper training.