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CLOSEOUT LETTER

Wintac Limited Jun 18, 2014

Wintac Limited - Close Out Letter 6/18/14


Wintac Limited

  

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

Public Health Service
Food and Drug Administration
CENTER FOR DRUG EVALUATION AND RESEARCH
 Office of Manufacturing and Product Quality
Division International Drug Quality
International Compliance Branch
10903 New Hampshire Avenue
Building #51, Room 4233
Silver Spring, MD 20993

TELEPHONE: (301) 796-3192
                 FAX: (301) 847-8742

 

June 18, 2014


S. Jayaprakash Mady
Managing Director
Wintac Limited
54/1, Boodihal Village, Nelamangala
Bangalore, 562123
India


Reference: FEI 3003821988


Dear S. Jayaprakash Mady:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-12-09, February 23, 2012. 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.

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/

Christina Alemu-Cruickshank
Compliance Officer
Division of International Drug Quality