Stryker shares dipped on the news and were trading $3.07 lower at $62.61 in early afternoon New York Stock Exchange trade.
CHICAGO (Reuters) - Stryker Corp <SYK.N> said on Friday its biotechnology division received a warning letter from U.S. health regulators regarding quality systems and compliance issues at its Hopkinton, Massachusetts, location.
Stryker shares dipped on the news and were trading $3.07 lower at $62.61 in early afternoon New York Stock Exchange trade.
The Food and Drug Administration warning letter concerns observations made during an inspection that started in September 2007, the company said.
Stryker said no products have been recalled as a result of the warning and there were no observations related to any ongoing clinical trial there.
!ADVERTISEMENT!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 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," Stryker said in a news release.
(Reporting by Debra Sherman; Editing by Andre Grenon)
