Sovereign Pharmaceuticals, LLC

CLOSEOUT LETTER Sovereign Pharmaceuticals, LLC MARCS-CMS 303858 — June 04, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: 2013-DAL-WL-28 Product: Drugs Recipient: Recipient Name Paul D. Hafey Recipient Title President and CEO Sovereign Pharmaceuticals, LLC 7590 Sand Street Fort Worth , TX 76118 United States Issuing Office: Center for Drug Evaluation and Research 4040 N. Central Expressway Suite 300 Dallas , TX 75204 United States Mr. Hafey: The Food and Drug Administration has completed evaluation of corrective actions in response to our Warning Letter 2013-DAL-WL-28, dated January 29, 2013. Based on our evaluation, 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/ John W. Diehl, M.S. Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division 2 Content current as of: 06/10/2019 Regulated Product(s) Drugs