Stryker Corporation today announced that it has been informed by the U.S. FDA that the actions undertaken by the company to address the issues raised in a 2007 Warning Letter are sufficient.
Stryker received the FDA Warning Letter from regarding compliance with certain quality system requirements at its reconstructive implant manufacturing facility in Mahwah, New Jersey.
Following an FDA re-inspection in 2009 and additional corrective actions, Stryker has been informed that issues raised have been adequately addressed and no further formal corrective actions are required.
“The resolution of the Mahwah, New Jersey Warning Letter is another important step in demonstrating our firm commitment to significantly transforming our quality systems throughout our organization,” Stephen P. MacMillan, Stryker’s chairman, president and CEO, said. “The investments we have made, and will continue to make, are resulting in solid progress toward our goals.”
Overall, Stryker received four FDA Warning Letters for its facilities in Ireland, Michigan, New Jersey and Massachusetts. The warnings for the Ireland and Michigan facilities are still in place, according to the FDA.