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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gunnell, Inc. - Close Out Letter 3/18/13

  

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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139

March 18, 2013


Changhai Chen, Ph.D
President and Owner
Chenica, Inc. dba Gunnell, Inc.
50 Enterprise Drive
Vassar, MI 48768


Dear Dr. Chen:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (2011-DET-04) dated November 9, 2010. 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/

Catherine V. Quinlan
Compliance Officer
District Director