FDA 483 - Surgtech Inc - May 07, 2025
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An FDA inspection of Surgtech Inc. in Westlake, OH, a medical device manufacturer, identified significant deficiencies in its quality system. The firm failed to adequately establish and implement procedures for design validation, design input requirements, and design transfer for its medical devices, including knee implants. Additionally, the inspection revealed inadequate control and monitoring over its high-risk contract manufacturer, impacting the assurance of device production capabilities.
ID · f3b6b42a-470f-416b-a2da-395d14cdee56