Essential Pharmacy Compounding

CLOSEOUT LETTER Essential Pharmacy Compounding MARCS-CMS 489638 — July 11, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day SIGNATURE CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Justin M. Kohll Recipient Title Owner Essential Pharmacy Compounding 12759 Q Street Omaha , NE 68137 United States Issuing Office: Center for Drug Evaluation and Research 300 River Place Suite 5900 Detroit , MI 48207 United States (313) 393-8100 Dear Mr. Kohll, The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter dated March 10, 2016 (Case #489638), which was issued under your firm’s former name, Essential Pharmacy Compounding. 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 ensure 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/ Nicholas F. Lyons Director Compliance Branch Division of Pharmaceutical Quality Operations III Content current as of: 07/15/2019 Regulated Product(s) Drugs