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FDA Says Stryker Addressed Warning Letter

2007 document said orthopedic device manufacturer wasn't in compliance with quality system requirements at New Jersey facility.

By: Editor

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Stryker Corp. has been informed by the U.S. Food and Drug Administration that actions the company have taken to address issues raised in a 2007 warning letter are sufficient, the Kalamazoo, Mich.-based firm said.

The orthopedic device manufacturer received a warning letter from the agency regarding compliance with quality system requirements at its reconstructive manufacturing facility in Mahway, N.J., in 2007, according to the firm.

Following FDA re-inspection last year and other corrective actions, the company has been informed that no further formal corrective actions are required, it said.

“The resolution of the Mahwah, N.J, warning letter is another important step in demonstrating our firm commitment to significantly transforming our quality systems throughout our organization,” said Stephen MacMillan, Stryker’s chairman, president and CEO.

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