Liberty Drug & Surgical

CLOSEOUT LETTER Liberty Drug & Surgical MARCS-CMS 485027 — February 25, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day Air Recipient: Recipient Name Alan Brown Recipient Title President Liberty Drug & Surgical Liberty Drug & Surgical 195 Main Street Chatham , NJ 07928 United States Issuing Office: Center for Drug Evaluation and Research United States Dear Mr. Brown: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter # 16-NWJ-05 dated March 14, 2016. We acknowledge that your firm no longer produces sterile drug products and in the absence of a valid patient-specific prescription or medication order, shall not prepare compounded non-sterile preparations for human use except to the extent permitted by Federal law. 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 assure 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/ Diana Amador-Toro Program Division Director Office of Pharmaceutical Quality Operations Division I Content current as of: 03/11/2019