N-Molecular Inc. d.b.a. SOFIE

CLOSEOUT LETTER N-Molecular Inc. d.b.a. SOFIE MARCS-CMS 553833 — July 02, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Certified Mail Return Receipt Requested Product: Drugs Recipient: Recipient Name Patrick W. Phelps Recipient Title President and CEO N-Molecular Inc. d.b.a. SOFIE SOPHIE Biosciences 6162 Bristol Parkway Culver City , CA 90230 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. Phelps: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (CMS # 553833) dated September 24, 2018. 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/ Stephanie Durso, Compliance Branch Director Office of Pharmaceutical Quality Operations, Division I Content current as of: 07/16/2019 Regulated Product(s) Drugs