Stryker warning letter is third in a year
This article was originally published in The Gray Sheet
Executive Summary
FDA cites Stryker's Biotech division for quality system and compliance violations observed during inspections initiated in September of its Hopkinton, Mass., facility in a warning letter dated April 25, 2008, the firm announced May 2. The missive is Stryker's third warning letter since March 2007 (1"The Gray Sheet" Jan. 21, 2008, p. 10). Stryker's Biotech division markets the firm's OP-1 Implant andOP-1 Putty, which contain a recombinant human osteogenic protein and are FDA-approved under Humanitarian Device Exemptions (HDEs) for spinal fusion and fracture repair. The warning letter cites Stryker Biotech for problems related to a past clinical trial, medical device reporting procedures and falsified hospital institutional review board (IRB) documentation used to approve the implantation of OP-1 devices. Stryker says the clinical study problems were unrelated to any pivotal trials for the products and no products have been recalled as a result. Stryker retrospectively filed the missing MDRs and is working to improve its reporting process, according to the company