483
Plaxtron Industrial (M) SDN. BHD.FDA 483 - Plaxtron Industrial (M) SDN. BHD. - August 15, 2024
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
Plaxtron Industrial (M) SDN. BHD. in Ipoh, Malaysia, was inspected by the FDA from August 12-15, 2024, and received six observations. The inspection revealed significant deficiencies in process validation, device history records, process monitoring, environmental controls, corrective and preventive actions, and equipment maintenance procedures. These issues indicate a systemic lack of adequate quality system controls for medical device manufacturing.
Open in Dashboard
ID · b18ef45b-fbb4-43b8-aad2-bfc33cec02c7