Brown's Compounding Center, Inc. - Close Out Letter 11/14/16
- Brown's Compounding Center, Inc.
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
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.
LaTonya M. Mitchell
Cc: Darby C. Brown, President and CEO
Brown's Compounding Center, Inc.
11753 Dunrich Road
Parker, CO 80138