Warning letterPosted July 22, 2025
FDA warning letter to O3UV, LLC
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
FDA posted a warning letter to O3UV, LLC on July 22, 2025; the letter is dated July 7, 2025. Subject: Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Issuing office: Center for Biologics Evaluation and Research (CBER).
On the record
- Company
- O3UV, LLC
- Subject
- Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
- Issuing office
- Center for Biologics Evaluation and Research (CBER)
- Letter dated
- 2025-07-07
- Posted by FDA
- 2025-07-22
- Source
- FDA warning letters ↗
CFR cited
The record cites 13 sections of 21 CFR Parts 801, 803, 807, 820 and 830.
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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