November 2012 Inspection of Portage, Mich. Facility Results in Warning from FDA Regarding Quality Issues, Marketing Practices
Stryker Corporation officials state that the company’s Instruments division has received a warning letter from the U.S. Food and Drug Administration (FDA) related to observations made during a November 2012 inspection at its Portage, Mich., 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 510(k) 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.