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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tedec-Meiji Farma, S.A. - 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
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


Date: June 21, 2013

Juan Luis de Castro
Technical and Operations Director
Tedec-Meiji Farma, S.A.
Caretera M-300, KM 30.500
Madrid, Spain

Dear Juan Luis de Castro:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 320-12-16 dated April 24, 2012. Based on our evaluation, 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.




Joseph E. Duran
Compliance Officer
Division of International Drug Quality