Warning letterPosted June 17, 2025
FDA warning letter to Nefeteri Wellness
Unapproved New Drugs
FDA posted a warning letter to Nefeteri Wellness on June 17, 2025; the letter is dated May 30, 2025. Subject: Unapproved New Drugs. Issuing office: Office of Unapproved Drugs and Labeling Compliance.
On the record
- Company
- Nefeteri Wellness
- Subject
- Unapproved New Drugs
- Issuing office
- Office of Unapproved Drugs and Labeling Compliance
- Letter dated
- 2025-05-30
- Posted by FDA
- 2025-06-17
- 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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From FDA warning letters. The record may have changed since it was read.
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