Stryker scrutinized
This article was originally published in The Gray Sheet
Executive Summary
Firm is cited for compliance issues related to one of its craniomaxillofacial (CMF) implant products previously sold through its CMF distribution facility in Portage, Mich., in a May 5 warning letter. The company is responding to FDA regarding the citations, Stryker says in a May 11 filing with the Securities and Exchange Commission. Stryker's CMF offerings include its line of Leibinger instruments. The firm is already addressing issues related to three previous warning letters for quality system and compliance violations (1"The Gray Sheet" Feb. 2, 2009, p. 11). In the SEC filing, Stryker also acknowledges receipt of a subpoena from the Attorney General of New Jersey seeking documents related to financial arrangements with clinical trial investigators; other firms also have reportedly been issued similar subpoenas (2"The Gray Sheet" May 11, 2009, p. 9)