FDA 483 - Dynamic Group, Inc - May 31, 2023

Dynamic Group, Inc., a manufacturer of Class II medical devices, was cited for significant deficiencies in process control and the handling of nonconforming products. The inspection revealed inadequate procedures for cleanroom certification, HEPA filter maintenance, and particulate testing, leading to continued manufacturing in non-compliant environments. Additionally, the firm failed to adequately establish and follow procedures for controlling nonconforming products, including insufficient documentation for rework activities and a lack of proper evaluation for product contamination.