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CLOSEOUT LETTER

Gregory S. Stone 10/05/2016

Gregory S. Stone - Close Out Letter 5/10/16


Gregory S. Stone

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 Food and Drug Administration
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
         FAX: (410) 779-5707

FEI: 3011805226


May 10,2016

Via UPS

Mr. Gregory S. Stone
1844 Stone Ridge Road
Austinville, VA 24312

Dear Mr. Stone:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to Warning Letter CMS # 481773, issued on December 2, 2015. Based on our evaluation, it appears you have addressed the violations 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/

David P. Rice
Compliance Officer
Baltimore District