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Posted July 14, 2022

FDA Warns Seller of Unauthorized COVID-19 Tests

On June 30, 2022, the FDA issued a warning letter to W.H.P.M, Inc. for distributing COVID antigen tests without approval, clearance, or authorization from the FDA while claiming to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. The agency also found these products to be misbranded because the company did not notify the agency of its intent to introduce the device into commercial distribution.

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