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  5. Magellan Rx Pharmacy, LLC - 536134 - 06/06/2019
  1. Warning Letters

CLOSEOUT LETTER

Magellan Rx Pharmacy, LLC MARCS-CMS 536134 —

Product:
Drugs

Recipient:
Recipient Name
Steffanie M. Mathewson
Recipient Title
Senior Legal Counsel
Magellan Rx Pharmacy, LLC

55 Nod Road
Avon, CT 06001
United States

Issuing Office:
Division of Pharmaceutical Quality Operations I

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

(973) 331-4900

Dear Ms. Mathewson:

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 # 536134) dated September 11, 2017. We acknowledge that your Astoria, New York, facility has closed, effective December 31, 2018, and relinquished its New York State Pharmacy License when the facility closed. 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, should your facility re-open. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Send your electronic response or request to orapharm1_responses@fda.hhs.gov. Please identify your response or related request with FEI #3012729025.

If you have any questions, contact Compliance Officer Juan Jimenez at juan.jimenez@fda.hhs.gov or 518-453-2314 X-1014.

/S/
Stephanie Durso
Director Compliance Branch
U.S. Food and Drug Administration
OPQO Division I / New Jersey District