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WARNING LETTER

July 7, 2025 

CBER 25-668840

Dear Mr. Lowe:

The United States Food and Drug Administration (FDA) inspected your facility located at 11968 Sweetwater Drive, Grand Ledge, MI 48837-8101, between August 23, 2023, and August 31, 2023. During the inspection, FDA documented that your firm manufactures autohemotherapy devices (1) Champion Full Spectrum (also included in Champion Full Spectrum: Starter Bundle; UV/Ozone Bundle; UV Automation Bundle; UV Complete Bundle) and (2) EBOO Full Spectrum UV (“your products”). Based on information and records gathered prior to, during, and/or after the inspection, your products are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act” or “FD&C Act”), 21 U.S.C. § 321(h), because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

For example, your products are intended to expose patient’s blood to ozone and ultraviolet light before being returned to the patient intravenously during ozone and ultraviolet (UV) blood irradiation (UBI) therapies or Extracorporeal Blood Oxygenation and Ozonation (EBOO). Your products are intended for use in the treatment of various diseases or conditions, such as autoimmune diseases, cardiovascular disorders, and respiratory diseases. Your products may be purchased through your website at www.o3uv.com. You have distributed your products to healthcare practitioners (e.g., physicians, nurses, etc.) throughout the United States.

Unapproved Device Violations

Your products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not for these devices have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because you did not timely notify the agency of your intent to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of the devices, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency, 21 CFR 807.81(b)(1)(i).

The kind of information you need to submit in order to obtain approval or clearance for your products is described at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. FDA will evaluate the information you submit and respond as appropriate.

UDI Violations

Your products are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that you failed or refused to furnish material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting these devices. In particular, the Unique Device Identification regulations at 21 CFR 830.300(a) and 830.320(b) – both of which were promulgated under section 519 of the Act, among other provisions – require that the labeler of a device submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR part 830, subpart E, for each version or model required to bear a unique device identifier (UDI). FDA has determined that your firm is a “labeler” within the meaning of 21 CFR 830.3 in that your firm causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. FDA has also determined that your firm has also failed to submit to the GUDID any information required by 21 CFR part 830, subpart E, respecting these devices.

The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. § 331(q)(1)(B).

Failure to Register and List

Under section 510 of the Act, 21 U.S.C. § 360, manufacturers of devices are required to annually register with FDA. Section 510 of the Act further requires domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means (section 510(p) of the Act, 21 U.S.C. § 360(p)) during the period beginning October 1 and ending December 31 of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2025 for your products. As a result, your products are misbranded within the meaning of section 502(o) of the FD&C Act, 21 U.S.C. § 352(o), in that your products were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360, and were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).

Your 483 Response

We acknowledge receipt of your letter dated September 25, 2023, which provides a response and corrective actions to FDA’s inspectional observations (FDA-483) and some discussion items. We have reviewed the corrective actions outlined in the response and concluded that they are not adequate. For example, your response did not address existing inventory manufactured under the conditions detailed in the FDA-483 or your continued manufacturing, marketing, and distribution of your products for use in the treatment of a host of medical conditions without authorization. Furthermore, you provided no detail regarding when you plan to implement the various procedures you stated you would develop.

Additional Concerns

FDA has significant concerns regarding your compliance with current good manufacturing practice (cGMP) requirements at section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation were not in conformity with the cGMP requirements of the Quality System Regulation found at 21 CFR part 820 at the time of our 2023 inspection. For example, at the time of this inspection, you failed to comply with the following requirements:

1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1).

Specifically, your firm had no design control procedures in place to control the design of devices. From January 1, 2022, to August 21, 2023, your firm distributed (b)(4) Champion Full Spectrum (Champion Full Spectrum UV Starter Bundle, Champion Full Spectrum UV/Ozone Bundle, Champion Full Spectrum UV Automation Bundle, Champion Full Spectrum UV Complete Bundle included) and (b)(4) EBOO Full Spectrum UV devices, which were not developed under any design controls.

2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

Specifically, your firm had no complaint procedure in place to receive, review, and evaluate complaints.

3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.

Specifically, your firm had no procedures in place to ensure that all products purchased from suppliers conform to specified requirements. Your firm purchased “ABLE® H-200 High Flux Polyethersulfone Disposable Haemodialysers” (i.e., hemodialyzer filters) sold as part of your 100 Pack EBOO Full Spectrum Kit and EBOO Full Spectrum UV. In addition, your firm purchased Hedy Vet Infusion Pumps sold solo or as a part of bundles (Champion Full Spectrum UV Automation Bundle and Champion Full Spectrum UV Complete Bundle). You did not evaluate these suppliers of these products; you did not establish the requirements, including quality requirements that must be met; and you did not establish purchasing data which includes, where possible, an agreement that the supplier, contractor, and consultants agree to notify the manufacturer of changes in the product or services.

4. Failure to establish and maintain procedures for implementing corrective and preventative action (CAPA), as required by 21 CFR 820.100(a).

Specifically, your firm had no corrective and preventive action procedures in place to correct and prevent recurrence of identified existing and potential causes of nonconforming product and other quality problems.

5. Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a).

Specifically,

a. Step (b)(4) of your firm’s untitled and uncontrolled work instruction for assembling and testing Champion Full Spectrum UV devices stated, “(b)(4).” The work instruction did not adequately describe the acceptance criteria that must be met. Moreover, you confirmed that test results were not documented.

b. Prior to this inspection, your firm did not have a documented work instruction for EBOO Full Spectrum UV device acceptance activities.

6. Failure to establish and maintain procedures to ensure that Device History Records (DHR's) for each batch, lot, or unit are maintained, as required by 21 CFR 820.184.

Specifically, your firm had no procedure in place to ensure that DHRs for each batch, lot, or unit are maintained.

7. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance, as required by 21 CFR 820.22.

Specifically, your firm had no procedure in place for quality system audits.

8. Failure of the management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures, as required by 21 CFR 820.20(c).

Specifically, your firm had no procedure in place for management review.

Additionally, the inspection revealed that your firm failed to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, your firm had no procedure for internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). A device is deemed to be misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), if there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, which includes adverse event reports required under 21 CFR part 803, respecting the device.

We are also concerned that, at least at the time of our inspection, the labels of your products did not bear a unique device identifier that meets the requirements of 21 CFR part 801, subpart B, and 21 CFR part 830, as required by 21 CFR 801.20(a). A device that fails to bear a UDI as required by the FD&C Act and implementing regulations is misbranded within the meaning of section 502(c) of the Act, 21 U.S.C. § 352(c), because a word, statement, or other information required by or under authority of the Act to appear on the label or labeling of the devices was not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Conclusion

We request that your firm immediately cease any activities that result in the misbranding or adulteration of your products and that your firm immediately cease committing any acts that are prohibited under the Act. You should take prompt action to address any violations.

This letter is not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure full compliance with all applicable requirements in the FD&C Act, the Public Health Service Act (“PHS Act”), and their implementing regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in legal action being initiated by FDA without further notice. Such actions may include seizure and/or injunction.

We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your products are in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.

Send your electronic response to CBERDCMRecommendations@fda.hhs.gov. If you have questions regarding this letter, contact the Division of Case Management, CBER at CBERDCMRecommendations@fda.hhs.gov.

Sincerely,
/S/

Melissa J. Mendoza
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research