FDA EIR - Stryker Medical Division of Stryker Corporation - March 01, 2017

Stryker Medical Division of Stryker Corporation underwent an FDA "for cause" inspection at its Portage, MI facility from February 22 to March 1, 2017. The inspection primarily focused on thermal regulator devices, including Medi-Therm and Altrix models, to assess design controls, corrective and preventive actions (CAPA), and production and process controls under relevant regulations. The inspection identified three main observations cited on an FDA Form 483. These included a failure to properly identify the scope of products affected in a field correction, a lack of design verification for cleaning and disinfection procedures outlined in product instructions, and the omission of inspection results from service reports generated during complaint investigations. The firm also had discussion items regarding complaint analysis, CAPA risk alignment, supplier process validation criteria, and overall complaint investigation thoroughness. Stryker Medical, an MDSAP participant and FDA-registered entity, is required to provide a written response to the Detroit District Director within five days, detailing their plan for corrections to address the identified issues.