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  5. Lupa Gourmet, Inc. - 492718 - 12/03/2018
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CLOSEOUT LETTER

Lupa Gourmet, Inc. MARCS-CMS 492718 — 03/12/2018

Lupa Gourmet, Inc. - 492718 - 12/03/2018


Recipient:
Recipient Name
Paolo Mannoni
Recipient Title
President
Lupa Gourmet, Inc.
Lupa Gourmet, Inc.

657 37th Street
Union City, NJ 07087-2514
United States

Issuing Office:
Office of Human and Animal Food Operations East Division I

United States


Dear Mr. Mannoni:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2016-30 dated March 21, 2016. 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/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East – Division 1