Homeocare Laboratories, Inc.

CLOSEOUT LETTER Homeocare Laboratories, Inc. MARCS-CMS 521717 — June 25, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Homeocare Laboratories, Inc. United States Issuing Office: United States Division of Pharmaceutical Quality Operations I 10 Waterview Blvd, 3rd FL Parsippany, NJ 07054 Telephone: (973) 331-4900 FAX: (973) 331-4969 CERTIFIED MAIL RETURN RECIPT REQUESTED June 25, 2018 Edith Scheiner, President HomeoCare Labs Inc. 7 Odell Plaza, Suite 142-146 Yonkers, NY 10701 Dear Ms. Scheiner: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (CMS # 521717) dated September 7, 2017. 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/ Yvette Johnson, Compliance Officer Office of Pharmaceutical Quality Operations, Division I Philadelphia District Office Content current as of: 06/26/2018