Stryker has resolved the second of four FDA warning letters it received in 2007 regarding problems at several of its facilities. The agency had expressed concern about Stryker's Mahwah, NJ, facility where the devicemaker manufactures reconstructive orthopedic implants. Following FDA re-inspection in 2009 and additional corrective actions, Stryker says that the issues have been resolved and no further 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," says Stephen MacMillan, Stryker's CEO, in a statement. "The investments we have made, and will continue to make, are resulting in solid progress toward our goals."
Stryker has spent $200 million since 2007 working to improve quality and compliance programs, according to the Wall Street Journal. Outsanding issues remain at the company's Cork, Ireland and Michigan plants.
- here's Stryker's release
- read the WSJ article for more