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  5. Millers of Wyckoff, Inc. - 484793 - 02/26/2019
  1. Warning Letters

CLOSEOUT LETTER

Millers of Wyckoff, Inc. MARCS-CMS 484793 —

Delivery Method:
UPS Overnight
Recipient:
Recipient Name
David M. Miller, R.Ph
Recipient Title
Owner/President
Millers of Wyckoff, Inc.
Millers of Wyckoff, Inc.

678 Wyckoff Avenue
Wyckoff, NJ 07481-1430
United States

Issuing Office:
Center for Drug Evaluation and Research

United States

(973) 331-4900

Dear Mr. Miller:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter # 16-NWJ-09, dated June 7, 2016. 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/
Stephanie Durso
Director, Compliance Branch
Office of Pharmaceutical Quality Operations
Division I

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