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General Medical Company, a maker of devices for excessive sweating, did not keep a record of verbal complaints and had problems with its complaint evaluations, the FDA found during an October 2015 inspection. Read More
Ethicon’s petition for an en banc hearing was rejected 10-1 by the Federal Circuit after the J&J subsidiary appealed a final decision by the PTAB in its patent battle with Medtronic over surgical stapler patents. Read More
Massachusetts medical device maker Analogic, agreed to pay nearly $15 million to settle civil and criminal actions involving Foreign Corrupt Practices Act violations. Read More
Berwickshire Electronic Manufacturing, a UK contract manufacturer, did not set requirements to evaluate suppliers and fell short on several other supplier control measures, according to an FDA warning letter. Read More