• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Stew Leonard's Holdings LLC - Close Out Letter 6/10/10

   

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

Public Health Service
Food and Drug Administration
  New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896

June 10, 2010

 

Mr. Stew Leonard, Jr.
President
Stew Leonard's Holdings, LLC.
100 Westport Avenue
Norwalk, Connecticut 06851-3915

 

Dear Mr. Leonard:

The Food and Drug Administration has completed an evaluation of your, firm's corrective actions in response to our Warning Letter NWE-06-10W dated October 28, 2009. 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/

Lori A. Holmquist
Compliance Officer
New England District Office
Augusta Maine Resident Post