483
Arboleaf CorporationFDA 483 - Arboleaf Corporation - April 18, 2025
Record Details
An FDA inspection of Arboleaf Corporation, an initial importer in Plano, TX, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for corrective and preventive actions, complaint handling, and Medical Device Reporting (MDR). These issues indicate a lack of fundamental quality control processes for imported medical devices.
- Office
- Dallas District Office
- Person
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ID · 72a8d198-f813-4ee0-a8b9-74fa454b83d5