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

Source: https://www.keypedia.com/records/eir/stryker-medical-division-of-stryker-corporation/d48d5369-e38e-42b0-8b80-86ad11ae718e

> FDA EIR for Stryker Medical Division of Stryker Corporation on March 01, 2017. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Stryker Medical Division of Stryker Corporation
- Inspection Date: 2017-03-01
- Product Type: devices
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Stryker Medical Division of Stryker Corporation's Portage, MI facility occurred from February 22 to March 1, 2017. This "For Cause" inspection specifically targeted Thermal Regulator medical devices, including Medi-Therm and Altrix models, within the framework of medical device quality system regulations. The inspection resulted in three significant observations on an FDA Form 483. These included the company's failure to accurately identify the scope of products impacted by a field correction, insufficient design verification for cleaning and disinfection protocols detailed in product instructions for use, and the absence of inspection findings in service reports for complaint investigations. Furthermore, discussions highlighted concerns regarding the inclusion of non-complaint data in analysis, corrective and preventive actions not aligning with risk levels, ambiguous acceptance criteria in supplier process validation, and general inadequacies in complaint investigations. Stryker, which participates in the MDSAP program and is FDA registered, committed to providing a written response to the FDA within five days, detailing their plan for addressing these observations and implementing necessary corrections.

## Related Documents

- [EIR - 2017-03-01](https://www.keypedia.com/records/eir/stryker-medical-division-of-stryker-corporation/51ff47a7-8a16-49bf-98d0-5e8d30cf8060)
- [EIR - 2017-03-01](https://www.keypedia.com/records/eir/stryker-medical-division-of-stryker-corporation/1538ce64-8df5-4bb5-a77c-be85bd90e090)
- [483 - 2024-11-15](https://www.keypedia.com/records/483/stryker-medical-division-of-stryker-corporation/b81c2c8a-3d51-48d5-8f89-3947ca79ef90)

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Company: https://www.keypedia.com/companies/stryker-medical-division-of-stryker-corporation/8540f6c7-6bb7-4c61-a1e6-cefe0fd53937

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d