FDA Issues Import Alert for MDR Violations

Swedish firm Cochlear Bone Anchored Solutions has been placed under a U.S. import alert for disagreements with the FDA over the appropriate level of adverse event reporting, according to a recently posted warning letter. An inspection of the firm’s plant found that its complaint-handling procedure does not detail how medical device reporting events will be investigated. Cochlear sent the FDA two letters in response, stating that it disagreed with the agency’s decision. For what it considers an inadequate response, the FDA issued the import alert — or detention without physical examination — on several of the company’s products.