CLOSEOUT LETTER
Spoonamore Drug Co Inc MARCS-CMS 455964 —
- Recipient:
- Spoonamore Drug Co Inc
United States
- Issuing Office:
United States
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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