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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Tosoh Bioscience Inc - Close Out Letter 11/4/11

  

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

Public Health Service
Food and Drug Administration
 

Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761

November 4, 2011

Ms. Susan H. Koss
Regulatory Affairs and Quality Assurance Manager
Tosoh Biosciences, Inc.
3600 Gantz Road
Grove City, Ohio 43123

Dear Ms. Koss:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CIN-11-124848-04, dated January 18, 2011. Based on our evaluation, it appears that you have addressed the violation(s) 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/

Toniette K. Williams
Director, Compliance Branch


 

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