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

An FDA inspection was conducted at Stryker Medical Division of Stryker Corporation in Portage, MI, from February 22 to March 1, 2017. This "For Cause" inspection primarily reviewed the company's Thermal Regulator devices (Medi-Therm and Altrix models) under FDA regulatory oversight, including previous findings and recall activities. The inspection identified several significant issues, documented in a 3-point FDA Form 483. Key violations included the failure to accurately define the scope of products affected by a field correction, a lack of verified design for cleaning and disinfection procedures as specified in product instructions, and the absence of complete inspection and result details in service reports for complaint investigations. Further concerns discussed involved the inclusion of non-complaint data in complaint analysis, corrective actions not proportional to identified risks, and unclear acceptance criteria in supplier process validations. In response, Stryker Medical management is required to submit a written plan within five days to address these observations and implement necessary corrections.