FDA Letter API

Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy

Letter data

Company
Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy
Recipient
Mark H. Mandel, PharmD | 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
Issue date
2021-02-04
Posted date
Not available
FDA office
Detroit District Office
Subject
Not available
Product
Drugs
CMS ID
547409
Reference number
Not available
FEI
Not available
Inspection dates
Not available

Normalized citations

21 CFR: None found

21 U.S.C.: None found

Related FDA links

No related FDA letter link is present in the source index.

Full source text

CLOSEOUT LETTER Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy MARCS-CMS 547409 — February 04, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 02/12/2021 Regulated Product(s) Drugs