Kings Park Slope Inc.

CLOSEOUT LETTER Kings Park Slope Inc. MARCS-CMS 439314 — November 15, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Reference #: NYK 2015-28 Product: Drugs Recipient: Recipient Name Dmitry Vagman Recipient Title VP & Pharmacist in Charge Kings Park Slope Inc. Kings Super Pharmacy/Kings Pharmacy 357 Flatbush Avenue Brooklyn , NY 11238 United States Issuing Office: Division of Pharmaceutical Quality Operations I 10 Waterview Blvd 3rd FL Parsippany , NJ 07054 United States (973) 331-4900 Dear Mr. Vagman: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK 2015-28, dated March 27, 2015. We acknowledge that Kings Park Slope, Inc. registered with FDA as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) on December 23, 2013, and officially de-registered on July 21, 2017. You are expected to take all necessary steps to ensure compliance with the FDCA 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. Send your electronic inquiries to orapharm1_responses@fda.hhs.gov . Please identify your communication with FEI #3007174596. If you have any questions, contact Compliance Officer Juan Jimenez at juan.jimenez@fda.hhs.gov or call 1-518-453-2314 X-1014. /S/ Craig Swanson Acting Program Division Director/District Director U.S. Food and Drug Administration OPQO Division I / New Jersey District Content current as of: 02/03/2020 Regulated Product(s) Drugs