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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Teco Diagnostics, Inc. - Close Out Letter 10/21/13

  

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

 
 Food and Drug Administration
Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax               (949) 608-4415

 

VIA UNITED PARCEL SERVICE


October 21, 2013


K.C. Chen
President/Co-Owner
Teco Diagnostics, Inc.
1268 N Lakeview Ave
Anaheim, CA 92807-1831


Dear Dr. Chen:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter WL # 40-10 dated August 20, 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/

Alonza E. Cruse
District Director
Los Angeles District