WARNING LETTER
CMS# 675673
Cue Health, Inc.
San Diego, CA
May 9, 2024
Inspection Dates: on 10 dates between October 17, 2023 and November 3, 2023.
Inspection Issue(s): “not complying with the following Conditions of Authorization in the Letters of Authorization for EUA200248 and EUA210180. For example:
- Evidence obtained during the inspection demonstrated that your firm implemented several changes to your EUA-authorized devices and implemented those changes without authorization from FDA pursuant to the Conditions of Authorization.
- Pursuant to Condition M (EUA200248) and Condition N (EUA210180), your firm is required to have lot release activities to ensure that the product released meets the clinical and analytical performance claimed in the authorized labeling.
Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.
