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

An FDA inspection of OPULENT SOLUTIONS SDN BHD, a foreign medical device manufacturer located in Malaysia, was conducted from May 15 to May 17, 2023. The inspection resulted in a Form FDA 483, highlighting significant observations related to the company's quality management system and adherence to medical device regulatory requirements. The primary issues identified included a lack of established process control procedures essential for ensuring product conformance to specifications. Investigators also noted that procedures for the rework of nonconforming products were not adequately established or consistently followed. Furthermore, deficiencies were found in the company’s document control system, specifically concerning the adequate maintenance and effective implementation of procedures for document review and approval. These observations indicate areas where the firm’s quality system requires enhancement to meet regulatory standards. OPULENT SOLUTIONS SDN BHD committed to correcting all identified observations, necessitating comprehensive corrective actions to address these quality system deficiencies and ensure compliance with medical device regulations.