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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Copious International, Inc. - Close Out Letter 4/22/13

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring. MD 20993-0002

 

APR 22 2013


Mr. Wen-Tau Liu
Chairman of the Board
Copious International, Inc.
No. 20, Alley 1, Lane 217, SEC. 3 Chung Shiao E. Rd
Taipei, Taiwan
China


Dear Mr. Liu:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated September 25, 2012 (CMS# 348538). 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 yours,

/S/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health

 

CC:


Mr. Sam Kao
KalMed Supply, Inc.
2700 N. Main Street
Suite 280
Santa Ana, California 92705


Ms. Xio Wen Li
General Manager
Copious International Inc.
Wei 11th Road, Huada Street
New City Area, Heyuan, Guangdong
China