Custom Compounding Center

CLOSEOUT LETTER Custom Compounding Center MARCS-CMS 481888 — October 28, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mark W. Shinabery Recipient Title Owner and Pharmacist-In-Charge Custom Compounding Center 11700 Kanis Rd Suite 1 Little Rock , AR 72211 United States Mark@customccrx.com Issuing Office: Office of Pharmaceutical Quality Operations, Division II United States Mr. Shinabery: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter 2016-DAL-WL-14, dated March 16, 2016. We acknowledge that your firm no longer produces sterile drug products. 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 John W. Diehl, M.S. Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Content current as of: 11/05/2020 Regulated Product(s) Drugs