Millers of Wyckoff, Inc.

CLOSEOUT LETTER Millers of Wyckoff, Inc. MARCS-CMS 484793 — February 26, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 03/11/2019