483
Contour Healer LLCFDA 483 - Contour Healer LLC - September 15, 2023
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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