CLOSEOUT LETTER

Martin Avenue Pharmacy, Inc. MARCS-CMS 447940 — October 16, 2017

Recipient:: Recipient Name

Thomas G. Marks; Recipient Title

President; Martin Avenue Pharmacy, Inc.; Martin Avenue Pharmacy; 1247 Rickert Drive
Naperville, IL 60540
United States

Issuing Office:: United States; 312-353-5863

Division of Pharmaceutical Quality Operations III
300 River Place, Suite 5900
Detroit, MI 48207
Telephone: (313) 393-8100
Fax: (313) 393-8139

October 16, 2017

UPS Next Day

Roopinder Ahluwalia, PharmD
Pharmacist-in-Charge
Martin Avenue Pharmacy, Inc.
1247 Rickert Drive, Suite 100
Naperville, IL 60540

Dear Dr. Ahluwalia:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (ref: WL# CHI-3-15) dated March 18, 2015. 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 assure 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