# FDA 483 - Avokaid, LLC - November 25, 2025

Source: https://www.globalkeysolutions.net/records/483/avokaid-llc/5b9264dd-98ef-47ec-9a7f-3aa24e10ce02

> FDA 483 for Avokaid, LLC on November 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avokaid, LLC
- Inspection Date: 2025-11-25
- Product Type: device
- Office Name: Dallas District Office
- Summary: Avokaid, LLC, a specification developer and initial importer of Class II medical devices in Plano, TX, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed a comprehensive lack of established procedures for critical areas such as Medical Device Reporting (MDR), complaint handling, quality audits, acceptance activities, supplier control, and corrective and preventive actions. These findings indicate a broad failure to implement essential quality system requirements for medical device operations.

## Related Documents

- [483 - 2025-11-25](https://www.globalkeysolutions.net/records/483/avokaid-llc/5e836ec1-edc0-44c7-afdf-a7b53da937ce)

## Related Officers

- [Jacey Roy](https://www.globalkeysolutions.net/people/jacey-roy/6c4d5a32-4aa3-43b0-a06f-40757863219e)

Company: https://www.globalkeysolutions.net/companies/avokaid-llc/8c297be8-783e-4abf-b7fb-66f7ed2f78b0

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