Kalman Health & Wellness, Inc. dba Essential Wellness Pharma 2

CLOSEOUT LETTER Kalman Health & Wellness, Inc. dba Essential Wellness Pharma 2 MARCS-CMS 487023 — September 11, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day Signature Required Reference #: # CHI-8-16 Product: Drugs Recipient: Recipient Name William J. Kalman Recipient Title President and Co-Owner Kalman Health & Wellness, Inc. dba Essential Wellness Pharma 2 4625 N University Street Peoria , IL 61614-5828 United States Issuing Office: Division of Pharmaceutical Quality Operations III (PHRM3) 300 River Place Suite 5900 Detroit , MI 48207 United States (313) 393-8100 Dear Mr. Kalman: 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 # CHI-8-16), dated July 22, 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. Sincerely, /S/ Nicholas F. Lyons Compliance Director Division of Pharmaceutical Quality Operations III Content current as of: 09/23/2019 Regulated Product(s) Drugs