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

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