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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Newport Lobster Company, Inc.- Close Out Letter 10/24/11

  

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
Phone: (781) 587-7500
FAX: (781) 587-7556

October 24, 2011

Mr. Kenneth Haslam
President
Newport Lobster Company, Inc.
1076 Aquidneck Avenue
Middletown, RI 02842-5204

Dear Mr. Haslam:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, dated February 28, 2011. 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.

If you have questions regarding any issues in this letter, please contact me at 781-587-7491.

Sincerely,

/s/

Karen Archdeacon
Compliance Officer
New England District