North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

CLOSEOUT LETTER North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding MARCS-CMS 642792 — January 27, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 03/20/2026 Regulated Product(s) Drugs