Morton Drug Company dba Morton LTC

CLOSEOUT LETTER Morton Drug Company dba Morton LTC MARCS-CMS 496920 — June 13, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 06/18/2019 Regulated Product(s) Drugs