Intrathecal Compounding Specialists, LLC

CLOSEOUT LETTER Intrathecal Compounding Specialists, LLC MARCS-CMS 610639 — January 19, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Kevin Schneider Recipient Title Owner Intrathecal Compounding Specialists, LLC 206A Jacob’s Run Scott , LA 70583-8907 United States Issuing Office: Division of Pharmaceutical Quality Operations II United States Dear Mr. Schneider: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL 610639) dated September 15, 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/ H.L Jamillah Selby Acting Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Content current as of: 02/14/2022 Regulated Product(s) Drugs