# FDA 483 - North American Diagnostics - June 23, 2022

Source: https://www.globalkeysolutions.net/records/483/north-american-diagnostics/6e7764d8-50c0-4ee5-a1a4-3135cb3bd89f

> FDA 483 for North American Diagnostics on June 23, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: North American Diagnostics
- Inspection Date: 2022-06-23
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of North American Diagnostics in Holly Hill, FL, revealed numerous significant quality system deficiencies related to their ORAL RAPID ™ SARS-CoV-2 Antigen Rapid Test Kit. The firm lacked established procedures for design control, production processes, process validation, acceptance activities, corrective and preventive actions, device distribution, complaint handling, and medical device reporting. Furthermore, the firm distributed its COVID-19 test kit without the required Emergency Use Authorization.

## Related Officers

- [Brandon P. Thompson](https://www.globalkeysolutions.net/people/brandon-p-thompson/a4e7da4f-2e9c-497c-ae4c-9168a9678b91)
- [Monica C. Burgos Garcia](https://www.globalkeysolutions.net/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.globalkeysolutions.net/companies/north-american-diagnostics/0212ec35-e1d6-42b1-a048-1effd86a1d10

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6