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CLOSEOUT LETTER

Kings Park Slope Inc. MARCS-CMS 439314 —

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