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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Capricorn Pharma Inc. Closeout Letter 3/16/11


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

Public Health Service
Food and Drug Administration

Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
Fax: (410) 779-5705 

FEI: 3002908878

March 16, 2011

Mr. Subraman Rao Cherukuri, President & CEO
Capricorn Pharma Inc.
6900 English Muffin Way
Unit A
Frederick, Maryland 21703

Dear Mr. Cherukuri:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 85885 issued April 20, 2010 and the most recent inspection conducted February 28, 2011 at your firm located at 6900 English Muffin Way, Unit A, Frederick, Maryland. Based on the evaluation of your responses and the follow-up inspection, it appears that you have addressed the violation(s) 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.

Randy F. Pack
Director, Compliance Branch

Cc: Mr. Kishore B. Gogineni, Director
Quality Assurance
Capricorn Pharma Inc.
6900 English Muffin Way
Unit A
Frederick, Maryland 21703