Inspections, Compliance, Enforcement, and Criminal Investigations
CareFusion Corp dba Productos Urologos De Mexico S.A. De C.V. - Close Out Letter 7/19/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
JUL 19, 2012
Mr. Rogelio Gutierrez
Director of Manufacturing Operations
CareFusion Corp dba Productos Urologos De Mexico S.A. De C.V.
Cerrada Via De La Produccion #85
Parque Industrial Mexicali Ill
Mexicali B.C., Mexico 21397
Dear Mr. Gutierrez:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS case #287859 issued on May 7, 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.
William C. McFarland
Division of Enforcement B
Office of Compliance
Center for Devices and