- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Reference #:
- NYK 2015-28
Recipient NameDmitry Vagman
Recipient TitleVP & Pharmacist in Charge
- Kings Park Slope Inc.
- Kings Super Pharmacy/Kings Pharmacy
357 Flatbush Avenue
Brooklyn, NY 11238
- Issuing Office:
- Division of Pharmaceutical Quality Operations I
10 Waterview Blvd
Parsippany, NJ 07054
- (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 email@example.com. Please identify your communication with FEI #3007174596.
If you have any questions, contact Compliance Officer Juan Jimenez at firstname.lastname@example.org or call 1-518-453-2314 X-1014.
Acting Program Division Director/District Director
U.S. Food and Drug Administration
OPQO Division I / New Jersey District