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  5. Morton Drug Company dba Morton LTC - 496920 - 06/13/2019
  1. Warning Letters

CLOSEOUT LETTER

Morton Drug Company dba Morton LTC MARCS-CMS 496920 —

Delivery Method:
UPS Next Day
Reference #:
MIN 17-01
Product:
Drugs
Recipient:
Recipient Name
Stephen C. Morton
Recipient Title
CEO
Morton Drug Company dba Morton LTC

201 E. Bell Street
Neenah, WI 54956-5096
United States

Issuing Office:
Center for Drug Evaluation and Research

300 River Place
Suite 5900
Detroit, MI 48207
United States

(313) 393-8100

Dear Mr. Morton:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to warning letter #MIN 17-01 dated October 26, 2016. Based on our evaluation, it appears that you have adequately addressed the violations contained in the 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 Compliance Branch
Division of Pharmaceutical Quality Operations III

 
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