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CLOSEOUT LETTER

Ercros S.A.


Ercros S.A.

  

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 Quality
Division of Drug Quality II
Global Compliance Branch 3
10903 New Hampshire Avenue
Building #51, Room 4243
Silver Spring, MD 20993
TELEPHONE: (301) 796-4668
FAX: (301) 847-8742 

March 15,2016

Dr. Maria Carmen Cruzado
Director of Pharmaceutical Division
Ercros, SA, Division Farmacia
Paseo del Deleite SIN
28300 Aranjuez (Madrid), Spain

Reference: FE! 3003562118

Dear Dr. Cruzado:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-12-020, January 20, 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.

Sincerely,
/S/
Ranjani Prabhakara
Compliance Officer
Division of Drug Quality II