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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Dr. Reddy's de Mexico - Close Out Letter 7/12/12


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

Public Health Service
Food and Drug Administration

Office of Manufacturing and Product Quality
Division of International Drug Quality
10903 New Hampshire Avenue
Building #51, Room 2238
Silver Spring, MD 20993
TELEPHONE: (301) 796-0491
FAX: (301) 847-8742

July 12, 2012

Mr. Jose Alberto Flores
Site Head
Dr. Reddy's de Mexico
Industria Quimicas Falcon de Mexico S.A. de C.V.
Km. 4.5 Carr. Fed. Cuemavaca-Cuautla
62578 CIV AC, Jiutepec, Morelos, Mexico

Reference: FEI 3002808297

Dear Mr. Flores:

The Food and Drug Administration has completed an evaluation of Dr. Reddy's de Mexico's corrective actions in response to our Warning Letter 320-11-014, June 3, 2011. 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.



Joseph Duran
Compliance Officer
Division of International Drug Quality