O3UV, LLC – FDA Warning Letter, Aug 31, 2023

**FDA Warning Letter Summary**

**Company:** [Name Redacted]

**Location:** 11968 Sweetwater Drive, Grand Ledge, MI 48837-8101, USA

**Inspection Dates:** August 23-31, 2023

**Main Violations/Issues:** 1. **Unapproved Devices:** The company manufactures and distributes autohemotherapy devices, including the Champion Full Spectrum and EBOO Full Spectrum UV, without necessary premarket approval (PMA) or investigational device exemption (IDE) as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act). 2. **Misbranding:** The devices are misbranded due to failure to notify the FDA of their commercial distribution, as required by section 510(k) of the FD&C Act. 3. **Unique Device Identification (UDI) Violations:** The company failed to submit required information to the FDA’s Global Unique Device Identification Database (GUDID). 4. **Failure to Register and List:** The company did not fulfill annual registration and listing requirements for fiscal year 2025. 5. **Current Good Manufacturing Practice (cGMP) Non-compliance:** The company did not meet cGMP requirements, including lack of design control procedures, complaint handling procedures, and supplier conformity assurance.

**Regulatory Framework:** - Devices are regulated under section 201(h) of the FD&C Act. - Violations include sections 501(f)(1)(B), 502(o), 502(t)(2), and 510 of the FD&C Act.

**Required Actions:** - Submit a premarket approval application or investigational device exemption. - Provide necessary UDI information to the GUDID. - Fulfill annual registration and listing obligations. - Implement corrective actions to address cGMP deficiencies, including establishing design control and complaint handling procedures.

The FDA requires the company to address these issues promptly to avoid further regulatory action.