U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Pagano's Inc. - Close Out Letter 9/1/15
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Pagano's Inc. 01/09/2015

Pagano's Inc. - Close Out Letter 9/1/15


Pagano's Inc.

  

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

 
 Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556

September 1, 2015

Ralph Pagano, Vice President
Pagano’s Inc.
142 Water Street
Norwalk, CT 06854

Dear Mr. Pagano:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS 443191, November 12, 2014]. 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/

Amber Wardwell
Director Compliance Branch
New England District