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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Abruzzino's Italian Bakery, LLC - Close Out Letter 8/13/10


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

Public Health Service
Food and Drug Administration
 Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
Fax: (410) 779-5707466

FEI: 3004192309

August 13, 2010

Certified Mail
Return Receipt Requested

Mr. Chris Abruzzino, Co-owner
Mr. Thomas Abruzzino, Co-owner and General Manager
Abruzzino’s Italian Bakery, LLC
Route 19
Gypsy, West Virginia 26361

Dear Messrs. Abruzzino:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 81125 dated December 1, 2009. Based on our evaluation, it appears that you have adequately 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.



Anne Aberdeen
Compliance Officer
Baltimore District