CLOSEOUT LETTER

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding MARCS-CMS 642792 — January 27, 2026

Delivery Method:: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED
Product:: Drugs

Recipient:: Recipient Name

Justin K. Graves; Recipient Title

Vice President; North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding; 1736 North Greenville Avenue
Richardson, TX 75081-1808
United States

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

Secondary Issuing Offices

United States

Dear Mr. Graves:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #642792, issued on November 18, 2022. 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