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

Source: https://www.keypedia.com/records/483/avokaid-llc/71df7f85-0973-4a6e-a580-8dc36961dd63

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

---

## Details

- Record Type: 483
- Company Name: Avokaid, LLC
- Inspection Date: 2025-11-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Avokaid, LLC, a specification developer and initial importer in Plano, TX, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies across its quality system, including a lack of established procedures for medical device reporting, complaint handling, quality audits, acceptance activities, supplier control, and corrective and preventive actions. These issues indicate a systemic failure to implement and maintain a compliant quality management system for medical devices.

## Related Documents

- [483 - 2025-11-25](https://www.keypedia.com/records/483/avokaid-llc/5b9264dd-98ef-47ec-9a7f-3aa24e10ce02)
- [483 - 2025-11-25](https://www.keypedia.com/records/483/avokaid-llc/5e836ec1-edc0-44c7-afdf-a7b53da937ce)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab