Horizon Pharmaceuticals, Inc.

CLOSEOUT LETTER Horizon Pharmaceuticals, Inc. MARCS-CMS 485363 — February 19, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS NEXT DAY DELIVERY Signature Required Product: Drugs Recipient: Recipient Name Ehab Ibrahim Recipient Title CEO Horizon Pharmaceuticals, Inc. 7880 Central Industrial Drive Riviera Beach , FL 33404 United States Issuing Office: Center for Drug Evauation and Research 4040 North Central Expressway Suite 300 Dallas , TX 75205 United States Dear Mr. Ibrahim: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter FLA-17-06 dated December 23, 2016. Based on our evaluation during the August 05, 2017 inspection of your firm, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ LCDR John W. Diehl, M.S. Compliance Branch Director Office of Pharmaceutical Quality Operations, Division II Content current as of: 08/28/2019 Regulated Product(s) Drugs