Stryker Corporation
Stryker's Biotech Division Receives FDA Warning Letter
Published in Medical Letter on the CDC and FDA, May 18th, 2008
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...
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