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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Evenbetternow, LLC. Close out Letter 3/3/11

   

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

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

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


May 3, 2011


Mitchell S. Fuerst, Esq.
Fuerst Ittleman, PL
1001 Brickell Bay Drive, Suite 2002
Miami, Florida 33131


Dear Mr. Fuerst:


This letter is to acknowledge receipt of your letter, dated April 8, 2011, submitted on behalf of your client, Evenbetternow, LLC (hereinafter Evenbetternow). This letter referenced your client's most recent corrective actions in response to our Warning Letter 03-11, dated October 12, 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 the 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 the firm to maintain compliance and will continue to monitor their 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/
William S. Vitale
Compliance Officer
Los Angeles District Office

 


Cc: Mr. Donald Nichols
      Ms. Andrea Nichols
      Evenbetternow, LLC
      1870 W. Prince Road, Suite 54
      Tucson, AZ 85705