Cue Health, Inc.

Warning LetterOpen

Mr. Clint Sever Chief Executive Officer Cue Health, Inc. 4980 Carroll Canyon Rd Ste 100 San Diego , CA 92121-1736 United StatesFEI 3016758165Issued May 9, 2024Center for Devices and Radiological Health

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3016758165.

Violations1

Issue DateMay 9, 2024

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Cue Health, Inc.
Location: Mr. Clint Sever Chief Executive Officer Cue Health, Inc. 4980 Carroll Canyon Rd Ste 100 San Diego , CA 92121-1736 United States
FEI Number: 3016758165
Country: United States
Issue Date: May 09, 2024
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

# Summary Cue Health, Inc. received a warning letter regarding manufacturing and quality system compliance violations for its Cue Health COVID-19 Test products, which are authorized diagnostic devices under Emergency Use Authorizations. The FDA conducted an inspection between October 17 and November 3, 2023, at the company's San Diego facility and identified Current Good Manufacturing Practice (CGMP) and Quality System Regulation (QSR) deficiencies that rendered the devices adulterated. The letter addressed both the laboratory-authorized version (EUA200248) and the home/over-the-counter version (EUA210180) of the COVID-19 test.

Cue Health, Inc. FDA Warning Letter, May 9, 2024