Warning Letter- Not Conforming to Manufacturing Requirements


Trexo Robotics Holdings, Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals:

CMS# 673150

Cue Health, Inc.

San Diego, CA

February 7, 2024

Inspection Dates: on June 3 through June 5, 2023

Inspection Issue(s): “the Trexo devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The Trexo devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction this device into interstate commerce for commercial distribution without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81.” For example:

• “your firm is marketing the Trexo devices for a different intended use; specifically, as a robotic powered gait training device to assist children with different levels of disability with ambulatory functions such as walking and standing.”
• “your device appears to operate using a different fundamental scientific technology than legally marketed devices in the generic type of device under 21 CFR 890.1925. For example, based on information in the product manual, the Trexo device use actuators such as a “powered hip joint” (part #1) and a “powered knee joint” (part #5) to generate forces or torques to the swing leg that assist human movement. In contrast, devices classified under 21 CFR 890.1925 are typically stationary machines that consist of a chair or a bench with a resistance mechanism that allows for controlled resistance for measuring muscular performance such as strength, power, and resistance.”

Your firm should provide evidence that the procedure has been updated to include all of the requirements of 21 CFR 820.30, and evidence of implementation of the validation activities that were conducted as part of the design control process for the Trexo devices.

Your firm should take prompt action to address any violations identified in this letter. Failure to promptly 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.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.

For more information, see the link below:

Trexo Robotics Holdings Inc. – 673150 – 02/07/2024 | FDA

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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