Warning letterPosted July 22, 2025

FDA warning letter to Nature’s Fusions LLC

CGMP/Finished Pharmaceuticals/Adulterated

FDA's record ↗

FDA posted a warning letter to Nature’s Fusions LLC on July 22, 2025; the letter is dated June 25, 2025. Subject: CGMP/Finished Pharmaceuticals/Adulterated. Issuing office: Center for Drug Evaluation and Research (CDER).

On the record

Company
Nature’s Fusions LLC
Subject
CGMP/Finished Pharmaceuticals/Adulterated
Issuing office
Center for Drug Evaluation and Research (CDER)
Letter dated
2025-06-25
Posted by FDA
2025-07-22
Source
FDA warning letters ↗

CFR cited

The record cites 6 sections of 21 CFR Parts 210 and 211.

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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