Stryker Corporation has reported that the FDA has informed the company that the actions undertaken to address issues raised in two warning letters received in 2007 and 2009 are sufficient.
Stryker has received a warning letter from FDA regarding compliance with certain quality system requirements at its reconstructive implant manufacturing facility in Cork, Ireland in 2007.
In 2009, Stryker has received another warning letter from FDA related to compliance issues for one of its craniomaxillofacial (CMF) implant products that was previously sold through its CMF distribution facility in Portage, Michigan.
Following FDA re-inspection of the Cork, Ireland facility and additional corrective actions at both the Cork and CMF facilities, the company has been notified that issues raised have been adequately addressed and no further formal corrective actions are required.
Stephen MacMillan, chairman, president and chief executive officer of Stryker, said: “We are highly encouraged that the corrective actions undertaken have been positively reviewed by FDA resulting in resolution of the two remaining Warning Letters. We are committed to ongoing investments in our compliance systems and believe this latest news supports the progress we are making in achieving our goals.”