Warning letterPosted August 25, 2026
FDA warning letter to R3 Medical Companies
Unapproved New Drugs/Unlicensed Biological Product Violations
FDA posted a warning letter to R3 Medical Companies on August 25, 2026; the letter is dated August 14, 2026. Subject: Unapproved New Drugs/Unlicensed Biological Product Violations. Issuing office: Center for Biologics Evaluation and Research (CBER).
On the record
- Company
- R3 Medical Companies
- Subject
- Unapproved New Drugs/Unlicensed Biological Product Violations
- Issuing office
- Center for Biologics Evaluation and Research (CBER)
- Letter dated
- 2026-08-14
- Posted by FDA
- 2026-08-25
- Source
- FDA warning letters ↗
CFR cited
The record cites 13 sections of 21 CFR Parts 210, 211 and 1271.
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 R3 Medical Companies
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 R3 Medical Companies.
See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.