Stryker gets FDA warning letter for Ireland plant
(Adds company comment)
CHICAGO, June 19 (Reuters) - U.S. regulators sent Stryker Corp. (SYK.N) a written warning, saying the artificial hip and knee maker has not completed promised fixes at a plant in Ireland, according to a letter posted by regulators on Tuesday.
The seven-page letter from the U.S. Food and Drug Administration cited several violations, including missed deadlines to fix failures in following procedures for testing problematic products and documenting risk analysis, among other issues.
The March 15 letter is heavily redacted, but it refers to a voluntary recall of "hip fracture stems" that the company completed earlier this year, which appears to be related to the problems.
It also cites several instances where the "root cause" of problems was not determined.
A Stryker spokesman, in a response via e-mail, said the company is working closely with the FDA to resolve the matter and that the plant is still operating.
The FDA issues dozens of warnings letters to manufacturers each year. While most are resolved without further action, the agency can impose penalties and hold up product approvals if problems persist.
((Reporting by Kim Dixon, editing by Maureen Bavdek; Reuters Messaging; kim.dixon.reuters.com@reuters.net; e-mail; kim.dixon@reuters.com, 1-312 408 8561)) Keywords: STRYKER FDA/
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