Warning letterPosted July 15, 2025
FDA warning letter to Hydroxie, LLC
Unapproved New Drug/Human Food/Adulterated
FDA posted a warning letter to Hydroxie, LLC on July 15, 2025; the letter is dated June 25, 2025. Subject: Unapproved New Drug/Human Food/Adulterated. Issuing office: Center for Drug Evaluation and Research (CDER).
On the record
- Company
- Hydroxie, LLC
- Subject
- Unapproved New Drug/Human Food/Adulterated
- Issuing office
- Center for Drug Evaluation and Research (CDER)
- Letter dated
- 2025-06-25
- Posted by FDA
- 2025-07-15
- Source
- FDA warning letters ↗
CFR cited
The record cites 1 section of 21 CFR Parts 170 and 181.
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 Hydroxie, LLC
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 Hydroxie, LLC.
See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.