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

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