# FDA 483 - Empowered Diagnostics LLC - February 25, 2022

Source: https://www.keypedia.com/records/483/empowered-diagnostics-llc/3203c013-6076-4876-815c-ae61f99a3204

> FDA 483 for Empowered Diagnostics LLC on February 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Empowered Diagnostics LLC
- Inspection Date: 2022-02-25
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

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Company: https://www.keypedia.com/companies/empowered-diagnostics-llc/764bf4ec-4c7c-4054-8f07-c5ed25b0f0bc

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6