FDA Shakes Head At Stryker's Plant Practices

Law360, New York (January 16, 2008, 12:00 AM EST) -- The U.S. Food and Drug Administration has warned Stryker Orthopedics Corp. that it may face regulatory action if it does not correct quality control issues with its joint replacement devices.

In a warning letter sent to Stryker CEO Steven MacMillan, which was posted on the FDA’s Web site on Tuesday, the agency accused the company of failing to meet federal regulations requiring procedures that avoid nonconformities, ensure consistency and control environmental conditions during the manufacture of medical devices.

After inspecting Stryker's Mahwah, N.J., plant between June...
To view the full article, register now.