CLOSEOUT LETTER

Advanced Nutriceuticals LLC dba The Guyer Institute of Molecular Medicine MARCS-CMS 615908 — February 24, 2026

Delivery Method:: Via Electronic Mail - Delivery and Read Receipt Requested
Product:: Drugs

Recipient:: Recipient Name

Leonard D. Guyer, MD; Recipient Title

Owner and President; Advanced Nutriceuticals LLC dba The Guyer Institute of Molecular Medicine; 836 E. 86th Street
Indianapolis, IN 46240-1806
United States

Issuing Office:: Division of Pharmaceutical Quality Operations Division III; United States

Secondary Issuing Offices

United States

Dear Dr. Guyer:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter, WL#615908, issued on November 10, 2021. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.

You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Matthew J. Lash
Acting Director
Office of Compounding Quality and Compliance
Office of Compliance
Center for Drug Evaluation and Research