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WARNING LETTER

LXR Biotech, LLC MARCS-CMS 714568 —

Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Mr. Anthony G. Orzechowski
Recipient Title
Vice President and Chief Operating Officer
LXR Biotech, LLC

2983 Waterview Dr.
Rochester Hills, MI 48309-4600
United States

Tonyo@lxrbiotech.com
Issuing Office:
Human Foods Program

United States

December 23, 2025

WARNING LETTER

CMS #613418

Dear Mr. Orzechowski,

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 2983 Waterview Dr., Rochester Hills, MI 48309 on February 25, 2025 through March 12, 2025. Based on inspectional findings, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.

At the conclusion of the inspection on March 12, 2025, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your responses dated April 3, May 2, and June 12, 2025, and we address you responses below.

Adulterated Dietary Supplements

The inspection of your facility on February 25, 2025 through March 12, 2025, identified serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplements Eternal Energy Grape and Eternal Energy Tropical Punch manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

Your significant violations of the CGMP requirements are as follows:

1. Your firm did not establish product specifications for identity, purity, strength, and composition of the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, your dietary supplement products Eternal Energy Tropical Punch and Eternal Energy Grape are manufactured using (b)(4). However, these ingredients are not included in your finished product specifications document.

We have reviewed your response dated May 2, 2025, including the finished product labels and finished product specification documents you provided. Your response states that “(b)(4)” and that your Eternal Energy Grape and Eternal Energy Tropical Punch products have been “(b)(4).” However, the finished product specification documents included with your response do not include all of the dietary ingredients listed in the new Energy Premix. For example, (b)(4) with your response for your Eternal Energy Grape and Eternal Energy Tropical Punch products.

In addition to establishing the required specifications, your firm must determine whether such specifications are met, in accordance with 21 CFR 111.73 and 111.75.

2. Your firm failed to establish an identity specification for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). Specifically, your specification document for the ingredient “(b)(4),” which is used in the manufacture of your Eternal Energy Tropical Punch product, states that you (b)(4). Your specification document for your ingredient “(b)(4),” which is used in the manufacture of your Eternal Energy Grape product, states that you (b)(4). However, because there are other substances that share the same established criteria, analysis of the factors listed above does not provide unique information that is specific to each of these ingredients and thus cannot confirm the identity of each ingredient.

3. You did not ensure that the tests and examinations you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1). Specifically, the finished product Eternal Energy Grape uses the component “(b)(4)” (listed as “(b)(4)” in the Batch Production Record). According to firm management, identity testing for this component is conducted by a third-party laboratory. Firm management stated that the supplier of your (b)(4). When the investigator requested identity testing results for (b)(4), your firm provided a certificate of analysis for (b)(4) from the third-party laboratory dated October 7, 2024, which showed the description of the sample as “(b)(4)” and the description of the standard it was tested against as “(b)(4).” The lot number of the tested material is identical to the supplier-provided reference standard. Your firm management was unaware of what material your supplier sent to the third-party laboratory to use as a reference standard, or if the material sent to the third-party laboratory was a valid standard to test against the (b)(4).

We have reviewed your response dated May 2, 2025. In your response, you state that the certificates of analysis from your supplier “(b)(4).” Further, you state that “(b)(4).” Thus, you state that “(b)(4).” However, for each specification that you are required to establish, you must take specific actions, after they are established, to verify that the specifications are met, as required by 21 CFR 111.73 and 21 CFR 111.75.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written reply should be directed to Lauren Crivellone, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS # 613418 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.

Sincerely,
/S/

Maria S. Knirk, J.D., M.B.A.
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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