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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Global Biotechnologies, Inc. - Close Out Letter 6/21/13

  

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

Public Health Service
Food and Drug Administration
 New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556

 

June 21,2013


Dr. A. Robert Bogosian
President
Global Biotechnologies Inc
54 York Street Suite 1B
Portland, ME 04101


Dear Dr. Bogosian:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS 302399. Based on our evaluation, it appears that 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. Please note, I inadvertently listed the Warning Letter CMS number as 68482 on the letter I previously sent you dated 5/31/2013. Please disregard that letter as this letter serves as the official correspondence regarding this matter.

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 regulation 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/

Amber G. Wardwell
Director Compliance Branch
New England District