FDA May Place UK, Denmark Device Firms on Import Alert, Conduct Reinspections for CGMP Violations
The Food and Drug Administration said in two warning letters that it may place devices manufactured by United Kingdom-based Integra Neurosciences (here) and Denmark-based Tonica Elektronik (here) on import alert after inspections revealed deviations from current good manufacturing requirements at…
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both companies’ facilities. Integra also offered for sale a non-FDA approved device in a catalog distributed in the U.S., FDA said in its warning letter to the company. Both facilities will be subject to reinspection to ensure compliance, FDA said.