Concord, Inc. dba Carlton's Dunwoody Pharmacy

CLOSEOUT LETTER Concord, Inc. dba Carlton's Dunwoody Pharmacy MARCS-CMS 512043 — November 18, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name Marvin O. McCord Recipient Title Owner Concord, Inc. dba Carlton's Dunwoody Pharmacy 5484 Chamblee Dunwoody Road Suite B19 Dunwoody , GA 30338-4133 United States Issuing Office: Office of Pharmaceutical Quality Operations, Division II United States Mr. McCord: 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 # 512043], dated August 20, 2017. 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 ensure 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/ John Diehl, M.S Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Cc: Tanja Battle, Executive Director Georgia State Board of Pharmacy (cover letter only) 2 Peachtree Street NW, 6th Floor Atlanta, GA 30303 Content current as of: 11/27/2019 Regulated Product(s) Drugs