FDA 483 - BK Medical Holding Company - May 27, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 01c02a91-48e2-443c-a2fb-963f8851d948