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  5. Brown's Compounding Center, Inc. - Close Out Letter 11/14/16
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CLOSEOUT LETTER

Brown's Compounding Center, Inc.


Brown's Compounding Center, Inc.

 

  

Black HHS-Blue FDA Logo

 

 

 
Denver District Office
6th Ave & Kipling Street
P.O. Box 25087
Denver, CO 80225
Telephone: (303) 236-3000
 

November 14, 2016
 

Perkins Coie LLP
Attention: T. Markus Funk
1900 Sixteenth Street
Suite 1400
Denver, CO 80202-5255
 

Re: Brown's Compounding Center, Inc.
 

Dear Mr. Funic

The U.S. Food and Drug Administration has completed an evaluation of your response to our warning letter (Ref.#: DEN-16-15-WL) dated August 17, 2016. We acknowledge that the firm has ceased production of drugs at its 13796 Compark Blvd., Englewood, Colorado facility. Therefore, there are no remaining compounding-related issues.

If the firm decides to resume operations in the future, please provide an explanation of each step being taken to prevent the recurrence of the violations cited in the waming letter, as well as copies of related documentation. In addition to taking appropriate corrective actions, the firm should notify this office prior to resuming production of any drug products in the future.

The firm is 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/
LaTonya M. Mitchell
District Director
Denver District
 

Cc: Darby C. Brown, President and CEO
Brown's Compounding Center, Inc.
11753 Dunrich Road
Parker, CO 80138