Spoonamore Drug Co Inc

CLOSEOUT LETTER Spoonamore Drug Co Inc MARCS-CMS 455964 — May 17, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Spoonamore Drug Co Inc United States Issuing Office: United States Division of Pharmaceutical Quality Operations III 300 River Place, Suite 5900 Detroit, MI 48207 Telephone: (313) 393-8100 Fax: (313) 393-8139 May 17, 2018 UPS NEXT DAY SIGNATURE REQUIRED Steven D. Williams President and Owner Spoonamore Drug Company, Inc. dba Louisville Pharmacy and Custom Script 4014 Dutchmans Lane, Suite 11 Louisville, KY 40207 Dear Mr. Williams: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [CIN-16-455964-04] issued on December 18, 2015. 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 Compliance Director Division of Pharmaceutical Quality Operations III Content current as of: 06/05/2018