483
SSN MEDICAL PRODUCTS SDN BHDFDA 483 - SSN MEDICAL PRODUCTS SDN BHD - May 10, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
Open in Dashboard
ID · 8ae00bcf-8dfa-4521-9874-d09eec0dad42