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Stryker Corporation announced today that its Biotech division has received a warning letter from the U. S. Food and Drug Administration (FDA) related to quality systems and compliance issues at its Hopkinton, Massachusetts location
KALAMAZOO, MI, USA | May 2, 2008 | Stryker Corporation (NYSE: SYK) announced today that its Biotech division has received a warning letter from the U. S. Food and Drug Administration (FDA) related to quality systems and compliance issues at its Hopkinton, Massachusetts location.
The warning letter concerns observations made during an inspection that was initiated in September 2007. The letter primarily cites issues relating to Stryker Biotech's handling of a past clinical study, its quality system including medical device reporting procedures, and the integrity of hospital Institutional Review Board (IRB) documentation used to approve implantation of Humanitarian Use Devices.
Several corrective actions and changes to processes put in place by Stryker Biotech were noted in the letter and future improvements are forthcoming as the division continues to work with FDA. No products have been recalled as a result of this warning letter. In addition, there were no observations related to any ongoing clinical trials or clinical trial IRBs.
"We take this matter very seriously, will continue to cooperate fully with FDA, and have initiated significant measures to address FDA's concerns," said Stephen P. MacMillan, President and Chief Executive Officer of Stryker Corporation.
In addition to specific corrective actions implemented at the Biotech division, Stryker recently launched a company-wide Quality Action Plan aimed at strengthening corporate-level oversight and at institutionalizing a more consistent implementation of best practices for meeting FDA requirements.
As part of its Quality Action Plan Stryker has
* Strengthened roles and responsibilities to increase accountability for quality
* Established new company-wide standard operating procedures for quality processes that will be implemented consistently at each division
* Reorganized quality functions at the plant, division and corporate levels and increased third-party monitoring at all levels
* Tied a significant portion of senior management's compensation to meeting quality improvement measures
"We are committed to strengthening our quality systems to fully meet all FDA requirements. While we have made progress in fulfilling this commitment, we still have more work to do" MacMillan added.
SOURCE: Stryker Corporation |
