Health Innovations Pharmacy, Inc

CLOSEOUT LETTER Health Innovations Pharmacy, Inc MARCS-CMS 489187 — April 21, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Health Innovations Pharmacy, Inc United States Issuing Office: United States Office of Pharmaceutical Quality Operations, Division 2 4040 N. Central Expressway, Suite 300 Dallas, Texas 75204 April 21, 2018 Mr. Timothy H. Clark, Owner Health Innovations Pharmacy, Inc. 295 Pinehurst Avenue Southern Pines, North Carolina 28387 Mr. Clark: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [WL #16-ATL-16] issued on July 8, 2016. We acknowledge that your firm no longer produces sterile drug products. 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. If you have additional questions, please contact me at (214) 253-5288 or john.diehl@fda.hhs.gov . Sincerely, /S/ LCDR John W. Diehl, M.S. Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division 2 Content current as of: 07/31/2018