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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Cordis LLC Close out Letter 12/15/11

   

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

Public Health Service
Food and Drug Administration
  466 Fernandez Juncos Avenue
San Juan, Puerto Rico, 00901
Telephone: 787-474-9500
FAX: 787-729-6658 

 

December 15, 2011


CERTIFIED MAIL
Return Receipt Requested


Mr. Seth Fisher, Cordis Company Group Chairman
Cordis LLC
7 Power Horn Drive
Warren, NJ 07059


Dear Mr. Fisher:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 11-SJN-WL-06 dated February 16, 2011. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter.


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.


Should you have questions and/or comments regarding this matter, please feel free to contact me at the district office address provide above in the letterhead. You may also contact Mr. Carlos A. Medina, Compliance Officer at telephone number 787-474-9538 or at carlosa.medina@fda.hhs.gov.

Kind regards,

/S/

Edwin Ramos
Director of Compliance
San Juan District Office