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CLOSEOUT LETTER

Plainsboro Pharmacy


Plainsboro Pharmacy

 

  

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New Jersey District
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, NJ 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969 

January 11, 2017
 

UNITED PARCEL SERVICE
Yousry Macksoud, RPh, Pharmacist-in-Charge and Owner
Plainsboro Pharmacy
9 Schalks Crossing Road, Suite 712
Plainsboro, NJ 08536

Dear Mr. Macksoud:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (ref: WL# 16-NWJ-12) dated August 1, 2016. We acknowledge your statements that “Plainsboro Pharmacy has ceased to fill all prescriptions containing the ingredient [liothyronine (T3)]” and “to ensure no further errors occur, a pharmacist is present with a technician throughout the entire duration of filling of a compounded prescription.” Based on our evaluation, it appears that you have 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/

Stephanie Durso
Acting Director Compliance Branch
New Jersey District