---

---

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 protected]. Please identify your communication with FEI #3007174596.

If you have any questions, contact Compliance Officer Juan Jimenez at [email protected] 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