PharmScript, LLC

CLOSEOUT LETTER PharmScript, LLC MARCS-CMS 535618 — July 29, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: #17-NWJ-11 Product: Drugs Recipient: Recipient Name Michael Segal Recipient Title CEO PharmScript, LLC 150 Pierce Street Somerset , NJ 08873 United States Issuing Office: Center for Drug Evaluation and Research 10 Waterview Blvd 3rd FL Parsippany , NJ 07054 United States (973) 331-4900 Dear Mr. Segal: 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 #17-NWJ-11; dated August 23, 2017]. 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/District Director OPQO Division I New Jersey District Office Content current as of: 08/07/2019 Regulated Product(s) Drugs