Warning letterPosted September 16, 2025
FDA warning letter to Elevate Your Wellness LLC, dba Elevated
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
FDA posted a warning letter to Elevate Your Wellness LLC, dba Elevated on September 16, 2025; the letter is dated September 9, 2025. Subject: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth). Issuing office: Center for Drug Evaluation and Research (CDER).
On the record
- Company
- Elevate Your Wellness LLC, dba Elevated
- Subject
- Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
- Issuing office
- Center for Drug Evaluation and Research (CDER)
- Letter dated
- 2025-09-09
- Posted by FDA
- 2025-09-16
- Source
- FDA warning letters ↗
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
More
Watch Elevate Your Wellness LLC, dba Elevated
A free account shows the last 7 days of every record. Pro adds a watchlist: one email when FDA acts on a company you name.
From FDA warning letters. The record may have changed since it was read.
Approve Suite is not affiliated with FDA, or with Elevate Your Wellness LLC, dba Elevated.
See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.