Warning letterPosted June 3, 2025
FDA warning letter to One Roof LLC
CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
FDA posted a warning letter to One Roof LLC on June 3, 2025; the letter is dated May 20, 2025. Subject: CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated. Issuing office: Human Foods Program.
On the record
- Company
- One Roof LLC
- Subject
- CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
- Issuing office
- Human Foods Program
- Letter dated
- 2025-05-20
- Posted by FDA
- 2025-06-03
- Source
- FDA warning letters ↗
CFR cited
The record cites 11 sections of 21 CFR Parts 101 and 117.
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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