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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mave Enterprises, Inc - Close Out Letter 8/9/11

  

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

August 09, 2011

Ms. Amy E. Grawitsky, President
Mave Enterprises, Inc.
11555 Cantara St. Ste B-E
North Hollywood, CA 91605-1652


Dear Ms. Grawitsky:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 27-11 dated February 16, 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/

Alonza E. Cruse, Director
Los Angeles District