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  5. Pine Pharmacy and Home Care Products Center, Inc. - 435704 - 04/25/2019
  1. Warning Letters

CLOSEOUT LETTER

Pine Pharmacy and Home Care Products Center, Inc. MARCS-CMS 435704 —

Delivery Method:
UPS Next Day Air
Reference #:
NYK-2015-24
Product:
Drugs

Recipient:
Recipient Name
Alfonse Muto, Sr.
Recipient Title
Owner
Pine Pharmacy and Home Care Products Center, Inc.

5110 Main Street
Williamsville, NY 14221
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. Muto:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of (your/your firm’s) corrective actions in response to our warning letter (ref: NYK-2015-24), dated February 13, 2015. 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
Office of Pharmaceutical Quality Operations - Division I
New Jersey District Office