FDA 483 - Unite Medical LLC - April 16, 2025
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An FDA inspection of Unite Medical LLC, a medical device manufacturer in Lithia Springs, GA, revealed significant deficiencies in their quality system. The firm failed to establish and implement essential procedures for complaint handling, supplier control, overall quality system management including audits, design control, and nonconforming product, as well as corrective and preventive actions. Additionally, their Medical Device Reporting (MDR) procedures were not properly implemented with required approval signatures and dates.
- Office
- Atlanta District Office
- Person
ID · 5c4c3c82-d5b8-47c5-a698-658655800f19