FDA 483 - AMSUSA LLC - May 06, 2025
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AMSUSA LLC in Atlanta, GA, was inspected by the FDA, resulting in two observations. The inspection revealed inadequate procedures for process changes, specifically regarding the relocation of manufacturing for Eclipse dental zirconia disc products without proper evaluation or documentation. Additionally, the firm lacked adequately established procedures for acceptance activities, leading to inconsistent final acceptance criteria for the Eclipse zirconia disc across various documents.
- Office
- Atlanta District Office
- Person
ID · 60d47ee0-bd02-4279-9729-bfeda9f8071c