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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Novartis International AG - Close Out Letter 7/16/14

  

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 and Product Quality
Division International Drug Quality
International Compliance Branch
10903 New Hampshire Avenue
Building #51, Room 4212
Silver Spring, MD 20993

TELEPHONE: (301) 796-3916
FAX: (301) 847-8742

 

July 16, 2014


Joseph Jimenez
Chief Executive Officer
Novartis International AG
Forum 1, Novartis Campus
CH-4056 Basel, Switzerland


Reference: FEI 3000280957, FEI 3000210731, and FEI 1717759


Dear Mr. Jimenez:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter WL: 320-12-05 dated November 18, 2011. 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,

/S/

Maan Abduldayem
Compliance Officer
Division of lnternational Drug Quality
Office of Manufacturing and Product Quality
Office of Compliance
Center for Drug Evaluation and Research