Stonegate Pharmacy LP

CLOSEOUT LETTER Stonegate Pharmacy LP MARCS-CMS 505526 — April 24, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS EXPRESS Product: Drugs Recipient: Recipient Name Rene F. Garza, PharmD Recipient Title Chief Executive Officer Stonegate Pharmacy LP 2501 W. William Cannon Drive Suite 203 Austin , TX 78745 United States Issuing Office: Center for Drug Evaluation and Research 4040 N. Central Expressway Suite 300 Dallas , TX 75204 United States Dr. Garza: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [2017-DAL-WL-03, dated November 10, 2016]. 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/ CDR John W. Diehl, M.S. Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Content current as of: 05/07/2019 Regulated Product(s) Drugs