Empowered Diagnostics LLC – FDA Warning Letter, Feb 25, 2022

The FDA issued a Warning Letter to a firm in Pompano Beach, Florida, following an inspection from February 3-25, 2022. The firm manufactures and distributes CovClear COVID-19 Rapid Antigen Tests and ImmunoPass COVID-19 Neutralizing Antibody Rapid Tests.

The inspection revealed that these COVID-19 Test Kits were distributed in the U.S. without FDA marketing approval, clearance, or authorization, rendering them adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Act. Additionally, labeling for ImmunoPass and some CovClear configurations falsely claimed EUA authorization, misbranding them under section 502(a).

The devices were also found to be adulterated under section 501(h) due to non-conformity with Quality System Regulation (21 CFR Part 820) current good manufacturing practice requirements. Violations included: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)), specifically inadequate design validation for CovClear. 2. Failure to adequately establish and implement corrective and preventive action procedures (21 CFR 820.100(a)), as evidenced by a lack of systematic investigation and corrective action for identified nonconformances. 3. Failure to adequately establish complaint handling procedures (21 CFR 820