Theoriginalhcgdrops.com - Close Out Letter 9/17/14
Department of Health and Human Services
|Food and Drug Administration|
Silver Spring, MD 20993-0002
September 17, 2014
Dr. Gary Arbuckle
Theoriginalhcgdrops.com and resetthebody.com
400 W 63rd St.
New York, NY 10069
Dear Dr. Arbuckle,
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter issued on November 28, 2011. Based on our evaluation of your written responses and the formulation changes you have made to the product(s) in question, it appears that you have addressed the violations contained in the 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.
LCDR Frank Verni, R.Ph.
U.S. Food and Drug Administration
158-15 Liberty Avenue, Room 4050
Jamaica, NY 11433
Phone: (718) 662-5702