Inspections, Compliance, Enforcement, and Criminal Investigations
Dr. Reddy's de Mexico - Close Out Letter 7/12/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
CENTER FOR DRUG EVALUATION AND RESEARCH
July 12, 2012
Mr. Jose Alberto Flores
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.
Division of International Drug Quality