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  5. Fallon Wellness Pharmacy, L.L.C. - 485889 - 12/18/2018
  1. Warning Letters

CLOSEOUT LETTER

Fallon Wellness Pharmacy, L.L.C. MARCS-CMS 485889 —

Delivery Method:
UPS NEXT DAY DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Peter L. Fallon
Recipient Title
Owner
Fallon Wellness Pharmacy, L.L.C.

1057 Troy-Schenectady Road
Latham, NY 12110-1002
United States

Issuing Office:
Center for Drug Evaluation and Research

United States

Dear Mr. Fallon:

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 # NYK-2016-23, dated February 1, 2016. We acknowledge that your firm no longer produces sterile drug products. 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
OPQO Division 1
New Jersey District Office

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