KALAMAZOO, Mich., May 2 /PRNewswire-FirstCall/ — 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.
Blast Your Resume to over 100 Pharmaceutical Recruiters and Employers
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
Leave a comment
You must be logged in to post a comment.