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CLOSEOUT LETTER

PharmScript, LLC MARCS-CMS 535618 — Jul 29, 2019

PharmScript, LLC - 535618 - 07/29/2019

Reference #:
#17-NWJ-11
Product:
Drugs

Recipient:
Recipient Name
Michael Segal
Recipient Title
CEO
PharmScript, LLC

150 Pierce Street
Somerset, NJ 08873
United States

Issuing Office:
Center for Drug Evaluation and Research

10 Waterview Blvd
3rd FL
Parsippany, NJ 07054
United States

(973) 331-4900

Dear Mr. Segal:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [WL #17-NWJ-11; dated August 23, 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/
Diana Amador-Toro
Program Division Director/District Director
OPQO Division I
New Jersey District Office