FDA 483 - OPULENT SOLUTIONS SDN BHD - May 17, 2023

An FDA inspection of OPULENT SOLUTIONS SDN BHD, a foreign medical device manufacturer in Bayan Lepas, Malaysia, revealed significant deficiencies in their quality system. The firm failed to establish adequate process control procedures, maintain proper rework procedures for nonconforming products, and effectively implement document control procedures. These observations indicate a need for comprehensive corrective actions to ensure compliance with regulatory requirements.