FDA WARNING_LETTER - Wello Inc. - June 21, 2023

On November 8, 2023, the FDA issued a Warning Letter to Wello, Inc. following an inspection from June 15-21, 2023, at their Addison, Texas facility. The inspection determined that Wello, Inc. manufactures the welloStationX, classified as a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The inspection revealed two primary violations:

1. **Misbranding under Section 502(c) for Failure to Have Compliant Labeling:** The welloStationX devices are misbranded because their labels lack a Unique Device Identifier (UDI) as required by 21 U.S.C. § 352(c) and 21 CFR 801.20(a). Specifically, the labels do not include a device identifier (21 CFR 801.3 or 830.3), a UDI in easily readable plain-text (21 CFR 801.40(a)(1)), or a UDI in machine-readable form using AIDC technology (21 CFR 801.40(a)(2)).

2. **Misbranding under Section 502(t)(2) for Failure to Submit Required Information to GUDID:** The devices are also misbranded because Wello