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  5. Trifarma S.p.A. - Close Out Letter 9/2/15
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CLOSEOUT LETTER

Trifarma S.p.A.


Trifarma S.p.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 2
Global Compliance Branch 4
10903 New Hampshire Avenue
Building #51, Room 4220
Silver Spring, MD 20993

TELEPHONE: (301) 796-3759
              FAX: (301) 847-8742

September 02, 2015

Mr. Giulio Volante
President
Trifarma S.p.A.
Via G. Guarini Matteucci 1
Milano 20162
Italy

Reference: FEI 3002807260

Dear Mr. Giulio Volante:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-14-10 dated July 07, 2014. 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.

If you have any questions regarding this letter, you may contact me at the above address or number.


Sincerely,

/S/

David S. Jones
Compliance Officer
Division of Drug Quality 2