483
Diamond OrthopedicDiamond Orthopedic – FDA 483, Apr 5, 2019
Record Details
An FDA inspection of Diamond Orthopedic in Charlotte, NC, a medical device manufacturer, revealed 11 significant quality system deficiencies. The firm failed to adequately manage complaints, control nonconforming products, establish proper CAPA procedures, and maintain accurate device history records. These issues indicate systemic problems in ensuring product quality and regulatory compliance.
- Office
- Atlanta District Office
- Person
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ID · d7fb6055-5d3d-4e6a-bdc8-a6e65f187549
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