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  5. Blue Ocean of Colorado, Inc. - Close Out Letter 9/28/17
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CLOSEOUT LETTER

Blue Ocean of Colorado, Inc.


Recipient:
Blue Ocean of Colorado, Inc.


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000              
FAX:        303-236-3100 
 
 

September 28, 2017

Ellen Y. Kim, Owner
Blue Ocean of Colorado, Inc.
3870 Paris Street, Unit 2
Denver, CO 80239

Dear Mrs. Kim:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter DEN-16-05-WL, dated January 27, 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/
La Tonya M. Mitchell
District Director, FDA Denver District
Program Division Director
Office of Human and Animal Foods - Division IV West