U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Concord, Inc. dba Carlton's Dunwoody Pharmacy - 512043 - 11/18/2019
  1. Warning Letters

CLOSEOUT LETTER

Concord, Inc. dba Carlton's Dunwoody Pharmacy MARCS-CMS 512043 —

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

Back to Top