Hans Zipperle, S.p.A.

CLOSEOUT LETTER Hans Zipperle, S.p.A. MARCS-CMS 501342 — November 13, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 11/19/2019 Regulated Product(s) Food & Beverages Juice