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Valeant Pharmacueticals International

Valeant Pharmacueticals International

United States

Issuing Office:

United States



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MDRHO, Division 1
One Montvale Ave
Stoneham, MA 02180 

June 13, 2017

Joseph C. Papa
Chairman and CEO
Valeant Pharmaceuticals International
400 Somerset Corporate Blvd.
Bridgewater, New Jersey 08807

Dear Mr. Papa:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2017-1, dated November 3, 2016. 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.

Sincerely yours,

Gina M. Brackett
Compliance Officer
Office of Medical Device & Radiological Health, Division 1


Cc: Stephen B. Haight
Vice President of Quality
1400 Goodman St. N
Rochester, NY 14609-3547

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