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CLOSEOUT LETTER

Casa di Pasta, Inc.


Casa di Pasta, Inc.

  

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

 
 Food and Drug Administration
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
         FAX: (410) 779-5707

FEI: 1180487


WARNING LETTER CLOSE-OUT LETTER


April 15th, 2015

Via UPS

Mr. Frank M. Velleggia, Owner
Casa di Pasta, Inc.
210 Albemarle Street
Baltimore, MD 21202

Dear Mr. Velleggia:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our follow-up inspection and FDA 483 “Inspectional Observations,” dated March 18th – 24th, 2015. The most recent follow-up inspection was as a result of the FDA inspection performed from March 18th – April 10th, 2014 which resulted in Warning Letter CMS # 429559, dated July 23rd, 2014. Based on our evaluation, it appears that you have addressed the violations contained in the most recent FDA 483 “Inspectional Observations” and the previous 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 yours,

/S/

David P. Rice
Compliance Officer
Baltimore District