Warning letterPosted June 10, 2025
FDA warning letter to Bio Wellness 444 LLC
Unapproved New Drugs/Misbranded
FDA posted a warning letter to Bio Wellness 444 LLC on June 10, 2025; the letter is dated May 30, 2025. Subject: Unapproved New Drugs/Misbranded. Issuing office: Center for Drug Evaluation and Research (CDER).
On the record
- Company
- Bio Wellness 444 LLC
- Subject
- Unapproved New Drugs/Misbranded
- Issuing office
- Center for Drug Evaluation and Research (CDER)
- Letter dated
- 2025-05-30
- Posted by FDA
- 2025-06-10
- Source
- FDA warning letters ↗
CFR cited
The record cites 2 sections of 21 CFR Parts 201 and 310.
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.
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