Recalls & Warnings
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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.
The unauthorized tests distributed by W.H.P.M include:
- First Sign COVID 19 Surveillance Test kit
- First Sign SARS-CoV-2 Antigen Test Packs (bulk products)
- COVISURE SARS-CoV-2 Antigen Test Kits
In addition, the agency found the test kits to be adulterated because methods used in the facilities are not in conformity with Current Good Manufacturing Practice (cGMP). The company also failed to maintain procedures to document product labeling as well as training records of staff.
The FDA instructed the company to send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov within 48 hours of receipt of the warning, describing the specific steps taken to correct misbranding violations. W.H.P.M, Inc must respond to and take action to correct any cGMP or Quality Systems violations within fifteen business days.
The unauthorized tests have been added to the FDA’s list of Fraudulent Coronavirus Disease Products.
See ConsumerLab’s review of at-home rapid antigen tests, including its Top Picks among these tests.
For more information, use the link below.
See related recalls and warnings:
FDA Warns 5 Sellers of Unapproved COVID-19 Tests
FDA Warns Consumers Not to Use LuSys Laboratories COVID Tests Due to False Results
FDA Warns Sellers of Unapproved COVID-19 Tests, CBD Products
FDA Warns Consumers about Fraudulent Tests, Vaccines, and Treatments for COVID-19
COVID Antibody and Antigen Tests That May Give False Results Recalled