Devices

Empowered Diagnostics Unapproved Covid Tests

A 3/3/22-3/25/22 FDA inspection at Empowered Diagnostics, Pompano Beach, FL, found that the firm manufactures and distributes several Covid-19 tests that have not received marketing approval, clearance, or authorization from FDA. A just-released 10/6/22 Warning Letter said some of the kits were misbranded because they contained statements that FDA had authorized the products for use under an emergency use authorization.

“These statements create a false impression that your products have been approved or authorized for emergency use by FDA, and are misleading,” the letter says. “As discussed above, none of your Covid-19 test kits has been approved, cleared, or authorized for emergency use by FDA.”

The inspection also determined that the devices were adulterated in they do not meet the requirements of the Quality System regulation. Specific violations were:

failing to establish and maintain design control procedures to ensure that specified design requirements of the device are met;
failing to adequately establish and implement corrective and preventive action procedures;
failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failing to adequately establish procedures for finished device acceptance;
failing to adequately establish procedures to ensure that all purchased or otherwise received products and services conform to specified requirements; and
failing to adequately establish and maintain document control procedures.

Empowered was told to take immediate action to address violations relating to the firm’s sale or distribution of its Covid-19 test kits and to prevent further violations. “We advise you to review your Web sites, product labels, and other labeling and promotional material to ensure that you are not misleadingly representing your products as safe and/or effective for a Covid-19 related use for which they have not been approved, cleared, or authorized by FDA and that you do not make claims that adulterate or misbrand the products in violation of the Federal Food, Drug, and Cosmetic Act,” the agency said.

The company was told to respond with a list of specific actions it has taken to address the Quality System concerns, with documentation of any corrections and a schedule for completing them.

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