Concord, Inc. dba Carlton's Dunwoody Pharmacy MARCS-CMS 512043 —
Recipient NameMarvin O. McCord
- Concord, Inc. dba Carlton's Dunwoody Pharmacy
5484 Chamblee Dunwoody Road
Dunwoody, GA 30338-4133
- Issuing Office:
- Office of Pharmaceutical Quality Operations, Division II
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.
John Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Cc: Tanja Battle, Executive Director
Georgia State Board of Pharmacy (cover letter only)
2 Peachtree Street NW, 6th Floor
Atlanta, GA 30303