Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts

CLOSEOUT LETTER Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts MARCS-CMS 559540 — January 20, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Jan R. Gerber Recipient Title Owner/President and CEO Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts 3510 N Ridge Rd. Suite 900 Wichita , KS 67205-1224 United States Issuing Office: Detroit District Office United States Dear Mr. Gerber: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (Case #559540), dated October 18, 2018). 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/ Nicholas F. Lyons Director of Compliance Branch Division of Pharmaceutical Quality Operations III Content current as of: 02/02/2022 Regulated Product(s) Drugs