# FDA WARNING_LETTER - Wello Inc. - June 21, 2023

Source: https://www.keypedia.com/records/warning_letter/wello-inc/bb4405f0-13b4-4228-b9ea-a927c9a6df0c

> FDA WARNING_LETTER for Wello Inc. on June 21, 2023. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Wello Inc.
- Inspection Date: 2023-06-21
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Acting Director](https://www.keypedia.com/people/courtney-h-lias/5e0a64fa-0140-4de2-9eed-929b12def9e9)
- [Program Division Director](https://www.keypedia.com/people/shari-j-shambaugh/aaea1185-eca8-41f8-bec7-d5d0024b582d)

Company: https://www.keypedia.com/companies/wello-inc/4bfb16cb-7282-4f94-b2b7-ebf9e5371800

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7