FDA 483 - SSN MEDICAL PRODUCTS SDN BHD - May 10, 2023

SSN MEDICAL PRODUCTS SDN BHD, a foreign medical device manufacturer in Seri Kembangan, Malaysia, was inspected by the FDA from May 8-10, 2023. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding document control, device history records, and complaint handling procedures. These issues indicate a lack of adequate controls for ensuring product quality and regulatory compliance.