Inspections, Compliance, Enforcement, and Criminal Investigations

Ameristar Casino Black Hawk - Close Out Letter 10/19/17

 

  

Black HHS-Blue FDA Logo

 

Denver District Office
6th Ave & Kipling Street
P.0. Box 25087
Denver, CO 80225 

 
 

October 19, 2017

Sean Demeule
Vice President and General Manager
Ameristar Casino Black Hawk
111 Richman Street
PO Box 45
Black Hawk, CO 80422

Dear Mr. Demeule:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter DEN-16-12-WL, dated July 28, 2016. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
LaTonya M. Mitchell
District Director, FDA Denver District
Program Division Director
Office of Human and Animal Foods - Division IV West

 

cc:

Anthony M. Sanfilippo, Chief Executive Officer
Pinnacle Entertaimnent
3980 Howard Hughes Parkway
Las Vegas, NV 89169 

Page Last Updated: 11/07/2017
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