# FDA WARNING_LETTER - North American Diagnostics, LLC - June 23, 2022

Source: https://www.keypedia.com/records/warning_letter/north-american-diagnostics-llc/2f26fa61-e7ba-4a85-81c9-af31f9322dfa

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

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## Details

- Record Type: WARNING_LETTER
- Company Name: North American Diagnostics, LLC
- Inspection Date: 2022-06-23
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: The FDA issued a Warning Letter to North American Diagnostics, LLC, following a June 14-23, 2022, inspection. The firm manufactures and distributes SARS-CoV-2 antigen rapid test kits under various names, including ORAL RAPID, SDI LABS, North American Diagnostics, Skippack Medical Labs, and Spectrum DX Lab.

The inspection revealed the COVID-19 Tests were distributed in the U.S. without FDA marketing approval, clearance, or authorization, making them adulterated under 21 U.S.C. § 351(f)(1)(B) and misbranded under 21 U.S.C. § 352(o) for failure to notify the agency per 21 U.S.C. § 360(k). The firm acknowledged "improperly distributed into commerce" the test kits.

Additionally, the COVID-19 Tests are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Violations include:
1. Failure to establish design control procedures (21 CFR 820.30(a)).
2. Failure to develop and control production processes (21 CFR 820.70).
3. Failure to validate processes where results cannot

## Related Officers

- [Director](https://www.keypedia.com/people/blake-bevill/7ed0dcde-28a7-452b-870d-6e085580abde)
- [Director](https://www.keypedia.com/people/timothy-t-stenzel/c53bdcbc-5f38-4c82-b8fc-181624201c10)

Company: https://www.keypedia.com/companies/north-american-diagnostics-llc/c77a670f-466d-4f9c-9272-3aaa58007263

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7