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  5. Spoonamore Drug Co Inc - Close Out Letter 5/17/18
  1. Warning Letters

CLOSEOUT LETTER

Spoonamore Drug Co Inc


Recipient:
Spoonamore Drug Co Inc


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
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