The Food and Drug Administration Tuesday warned another COVID-19 testing firm that its rapid antigen tests were not approved by regulators and the company must halt their sale.
Based on an inspection of USA Medical LLC’s facilities in Grapevine, Tex., between Feb. 28 and March 15, the FDA found that the company was manufacturing and distributing the tests without approval, clearance or authorization.
The warning letter notes that the company was selling tests with misleading labels indicating the tests were authorized under an emergency use authorization (EUA). The firm also didn’t notify the FDA of its intent to start selling the tests, and its facilities did not meet good manufacturing practice requirements, the agency said.
“Your products are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because labeling distributed with these products included statements that the products are authorized for use under an Emergency Use Authorization (EUA),” the FDA wrote. “These statements create a false impression that your products have been approved or authorized for emergency use by FDA and are misleading. As discussed above, none of your COVID-19 Test Kits have been approved, cleared, or authorized for emergency use by FDA.”
The company must take immediate action to halt the sale of the unauthorized test kits and to prevent future violations, the FDA said. Within 48 hours, USA Medical must also send an email describing specific steps the company is taking to address any violations.
The warning letter is one of several actions taken to crack down on unauthorized COVID-19 tests. Earlier this year, the FDA reported multiple Class I recalls of test kits that had been wrongly imported or were sold to customers despite being for research use only.
By publication time, the company had not responded to a request for comment.
