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.

  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy - 547409 - 02/04/2021
  1. Warning Letters

CLOSEOUT LETTER

Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy MARCS-CMS 547409 —

Delivery Method:
UPS Next Day
Product:
Drugs

Recipient:
Recipient Name
Mark H. Mandel, PharmD
Recipient Title
Owner and Pharmacist-in-Charge
Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy

384 E. Irving Park Road
Roselle, IL 60172-2007
United States

Issuing Office:
Detroit District Office

United States

(313) 393-8100

Dear Dr. Mandel:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (Case # 547409) dated February 27, 2018. 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/
Nicholas F. Lyons
Director of Compliance
Division of Pharmaceutical Quality Operations III

Back to Top