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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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SNBL USA LTD. - Close Out Letter 11/08/2012

  

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

Public Health Service
Food and Drug Administration
 Silver Spring, MD 20993

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Thomas W. Beck, Ph.D.
President and COO
SNBL USA, Ltd.
6605 Merrill Creek Parkway
Everett, WA 98203


Dear Dr. Beck:


The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [10-HFD-45-08-01 issued on August 9, 2010]. 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/

Thomas N. Moreno, M.S.
Director (Acting)
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Office of Medical Products and Tobacco
Food and Drug Administration


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This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
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/s/
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THOMAS N MORENO
11/08/2012