No More Warnings

For the first time in three years, Stryker Corp. has a clean record with the U.S. Food and Drug Administration (FDA). The Kalamazoo, Mich.-based orthopedic giant has resolved the last of four FDA warning letters it received since 2007.

Stryker executives said the FDA has lifted warning letters issued to the company for compliance issues at its reconstructive implant manufacturing facility in Cork, Ireland, and with a craniomaxillofacial (CMF) product previously sold through a distribution facility in Portage, Mich. CMF products can fix facial fractures and often are used in reconstructive surgery.

“We are highly encouraged that the corrective actions undertaken have been positively reviewed by FDA resulting in resolution of the two warning letters,” Stephen P. MacMillan, Stryker chairman, president and CEO, said in a prepared statement. “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.”

Stryker has made a significant investment in improving its compliance systems. Over the last three years, the company has spent more than $200 million to standardize quality throughout its 12 divisions and across its supply base. Initial target areas included the vendor validation process (more effort is now being made to share vendor audits and performance metrics, for example), the inspection process, and Stryker’s system for monitoring key quality data. Executives also have created and introduced at the firm a more formal quality system that sets minimum consistent standards in such matters as compliant investigations, design controls for new product development, and production processes.

Stryker executives did not explain how the compliance issues cited by the FDA were resolved, saying only that “corrective actions” were taken at the affected locations.

Stryker received its first warning letter in early 2007 for various compliance issues at Irish facility. Those issues included an untimely fix of failures and procedural noncompliance in the testing of failed or otherwise problem-prone devices. That letter took the longest to resolve.

The second FDA warning letter came in November 2007 for problems at the company’s Mahwah, N.J., plant. The problems included poor fixation of hip implant components, high microbial levels in the cleaning and final packaging areas of sterile implants, and the failure to institute measures to prevent these and other problems. The third warning letter was issued to the firm’s Hopkinton, Mass.-based biotechnology facility in April 2008 for—among other issues—its handling of a past clinical study, its quality system including medical device reporting procedures, and the integrity of hospital Institutional Review Board documentation used to approve implantation of humanitarian use devices, according to a Stryker news release. The fourth, and final, letter (about compliance issues with a CMF implant product) came in May 2009.

Stryker resolved the warning letter about its biotechnology facility last fall, and in March, the FDA lifted its warning letter about the New Jersey facility. And while MacMillan is happy to have no more outstanding letters, he believes the company’s efforts to improve its quality system are “far from over.” Companies, he noted, should not suspend their self-improvement efforts with the resolution of warning letters.