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  5. Hans Zipperle, S.p.A. - 501342 - 11/13/2019
  1. Warning Letters

CLOSEOUT LETTER

Hans Zipperle, S.p.A. MARCS-CMS 501342 —

Product:
Food & Beverages
Juice

Recipient:
Recipient Name
Thomas Brandstaetter
Recipient Title
Managing Director
Hans Zipperle, S.p.A.

Via Max-Valier, 3, C.P. 238
39012 Merano BZ
Italy

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

5001 Campus Drive
College Park, MD 20740
United States


Dear Mr. Brandstaetter:

The Food and Drug Administration (FDA) conducted a follow-up inspection of your manufacturing facility to evaluate your firm’s corrective actions in response to our Warning Letter #501342, issued September 7, 2016. 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 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/
Maria Corpuz
Team Leader
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition