KALAMAZOO – Stryker Corporation said Tuesday that its Biotech division has received a warning letter from the U. S. Food and Drug Administration 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 Stryker CEO Stephen P. MacMillan.
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 said.
For more information, click on Stryker.Com
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