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  5. Jubilant HollisterStier General Partnership - 09/05/2014
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CLOSEOUT LETTER

Jubilant HollisterStier General Partnership


Recipient:
Jubilant HollisterStier General Partnership

United States

Issuing Office:

United States


  

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 of International Drug Quality
10903 New Hampshire Avenue
Building #51, Room 4220
Silver Spring, MD 20993

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

 

September 05, 2014


Marcelo A. Morales, CEO
Jubilant HollisterStier General Partnership
16751 Rte Trans Canada
Kirkland, Canada H9H 4J4


Reference: FEI 3001623073


Dear Mr. Morales:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter WL 320-13-08. 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/

David S. Jones
Consumer Safety Officer
Division of International Drug Quality
CDER/OC/OMPQ