483
Stryker Medical Division of Stryker CorporationStryker Medical Division of Stryker Corporation – FDA 483, Nov 15, 2024
Record Details
An FDA inspection of Stryker Medical Division of Stryker Corporation in Portage, MI, revealed two significant observations regarding their quality system. The firm failed to adequately establish design verification procedures, specifically concerning worst-case product configuration, and did not adequately validate a critical manufacturing process parameter for the Power Pro 2 device.
- Inspection date
- November 15, 2024
- Product type
- device
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ID · b81c2c8a-3d51-48d5-8f89-3947ca79ef90
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