Empower Clinic Services, LLC

CLOSEOUT LETTER Empower Clinic Services, LLC MARCS-CMS 516718 — October 22, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS OVERNIGHT MAIL Reference #: 3011887629 Recipient: Recipient Name Arta Shaun Noorian Recipient Title Owner Empower Clinic Services, LLC Empower Clinic Services, LLC 5980 West Sam Houston Parkway North Suite 300 Houston , TX 77041 United States Issuing Office: Division of Pharmaceutical Quality Operations II 4040 N. Central Expressway Suite 300 Dallas , TX 75204 United States (214) 253-5200 Mr. Noorian, The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s response to our warning letter (Reference CMS Case #516718) dated May 25, 2017. From November 9, 2015, to November 25, 2015, FDA investigators conducted an inspection of your facility, Empower Clinic Services, LLC, located at 12123 Jones Rd., Houston, Texas 77070. We acknowledge that your firm ceased compounding operations on April 2, 2016 and moved to its newly constructed facility located at 5980 West Sam Houston Pkwy North, Suite 300, Houston, Texas 77041, and registered as a 503B outsourcing facility on July 16, 2016. 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. If you have any questions about this letter, you may contact me by e-mail at John.Diehl@fda.hhs.gov or by phone at 214-253-5288. Sincerely, /S/ LCDR John W. Diehl, M.S. Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Content current as of: 10/25/2018