FDA 483 - Empowered Diagnostics LLC - February 25, 2022

An FDA inspection of Empowered Diagnostics LLC, a medical device manufacturer in Pompano Beach, revealed significant quality system deficiencies related to their CovClear COVID-19 Rapid Antigen Test. The firm failed to establish adequate procedures for design control, corrective and preventive actions, complaint handling, finished device acceptance, supplier control, and document control. These issues contributed to the distribution of unvalidated products and a voluntary recall due to lack of FDA authorization.