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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Cortechs Labs Inc - Close Out Letter 7/18/11

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415
 

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

July 18, 2011

Mr. Michael E. Smith, President
Cortechs Lab, Inc.
1020 Prospect St., Ste. 450
La Jolla, CA 92037

Dear Mr. Smith:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter WL # 42-10, dated 09/01/10. 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/

Alonza E. Cruse
District Director
Los Angeles District