# FDA 483 - Arboleaf Corporation - April 18, 2025

Source: https://www.globalkeysolutions.net/records/483/arboleaf-corporation/72a8d198-f813-4ee0-a8b9-74fa454b83d5

> FDA 483 for Arboleaf Corporation on April 18, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arboleaf Corporation
- Inspection Date: 2025-04-18
- Product Type: device
- Office Name: Dallas District Office
- Summary: 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.

## Related Officers

- [Katherine M. Thames](https://www.globalkeysolutions.net/people/katherine-m-thames/06a4ece2-7417-42d5-93ab-d744aa5279eb)

Company: https://www.globalkeysolutions.net/companies/arboleaf-corporation/fe88daac-d7f1-4454-8755-e3169086f0da

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9