483
Contour Healer LLCContour Healer LLC – FDA 483, Sep 15, 2023
Record Details
An FDA inspection of Contour Healer LLC in Virginia Beach, VA, a manufacturer of Contour Healer devices, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for acceptance activities, purchasing controls, and management review. These issues indicate a lack of robust quality management practices.
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ID · 772e9377-adea-41a1-be8d-a134818c9642
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