First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

CLOSEOUT LETTER First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy MARCS-CMS 610384 — February 13, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Dawn T. Hoang Recipient Title Co-Owner First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy 6828 E. Brown Rd. Ste. 101 Mesa , AZ 85207 United States Issuing Office: Division of Pharmaceutical Quality Operations IV United States Dear Ms. Hoang: The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter, CMS 610384, issued September 8, 2020. 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/ CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV Content current as of: 02/17/2023 Regulated Product(s) Drugs