483
SSN MEDICAL PRODUCTS SDN BHDFDA 483 - SSN MEDICAL PRODUCTS SDN BHD - May 10, 2023
Record Details
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.
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ID · 8ae00bcf-8dfa-4521-9874-d09eec0dad42