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  5. Horizon Pharmaceuticals, Inc. - 485363 - 02/19/2018
  1. Warning Letters

CLOSEOUT LETTER

Horizon Pharmaceuticals, Inc. MARCS-CMS 485363 —

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