Stryker receives FDA warning letter regarding inspection of Portage, MI location Stryker announced that its Instruments division has received a warning letter from the FDA related to observations made during a November 2012 inspection at its Portage, Michigan location. The letter concerns quality system observations made during the inspection and cites Stryker for failing to notify the FDA of a product recall, and for marketing devices, including the Neptune Waste Management System, without a required 510k clearance. The letter acknowledged that Stryker Instruments has already submitted corrective action plans for the quality system and recall observations. The company is fully cooperating with the FDA to resolve these matters in a comprehensive and timely manner.
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