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  5. Hans Zipperle, S.p.A. - 501342 - 09/07/2016
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Hans Zipperle, S.p.A. MARCS-CMS 501342 —

Hans Zipperle, S.p.A.

United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


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

Public Health Service
Food and Drug Administration
 College Park, MD  20740 


September 7, 2016
Dr. Thomas Brandstaetter
Managing Director
Hans Zipperle, S.p.A.
Via Max-Valier, 3, C.P. 238,
Merano, Bolzano, Italy 39012
Reference No. # 501342
Dear Dr. Brandstaetter:
In response to a request by the United States Food and Drug Administration (FDA) for additional information including a copy of your firm’s most current Hazard Analysis and Critical Control Points (HACCP) plan for your juice products, your firm provided a copy of your HACCP plan for your apple juice concentrate and apple puree products dated February 26, 2016 via email on May 18, 2016, along with a description of your practices and procedures for controlling the food hazard of patulin via email on July 4, 2016. We have evaluated the documentation and found that you have a continuing serious deviation of the juice HACCP regulation, as further explained in this letter.
In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with 21 CFR 120, or otherwise operate in accordance with the requirements of this part, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 342 (a)(4). Accordingly, your apple juice concentrate and apple puree products are adulterated in that they have been prepared packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant deviation is as follows:
Your HACCP plan must, at a minimum, list all food hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). A “food hazard” is defined in 21 CFR 120.3(g) as “any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” However, your HACCP plan dated February 25, 2016, for apple juice concentrate and apple puree does not list the food hazard of patulin. Patulin contamination of apples is a food hazard that is reasonably likely to occur and would necessitate a critical control point for its control.
According to your July 4, 2016 response “the [patulin] risk is managed by a close monitoring system, the limits are defined by the European regulation 1881/2006 and clients specification which are normally stricter than the law. Furthermore we have to report for nearly every loading of apple products the patulin value to the client on the according CoA.” However, prerequisite programs such as the one you describe are not adequate substitutes for control measures included in a HACCP plan because they do not meet the regulatory requirements of the juice HACCP regulation, 21 CFR 120. Consequently, your firm needs to identify patulin as a food hazard in your HACCP plan and include adequate corresponding critical limits, monitoring procedures, recordkeeping, etc., to control the hazard.
Even a small percentage of rotten, moldy, and damaged apples may contain high enough levels of patulin to result in the finished product exceeding FDA’s 50 ppb action level. Therefore, any apples which are rotten, moldy, bruised or damaged should be trimmed or culled from production. Additional information regarding the chemical hazard of patulin and possible controls measures to be incorporated into your juice HACCP plan(s) can be found at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm072557.htm.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct this deviation. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or plans, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations. Submission of the information in English will assist in our review.  If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violation(s).
If you do not respond or if we find your response inadequate, we may take further action.  For instance, we may take further action to refuse admission of your imported juice products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the juice HACCP regulation is Import Alert #20-07. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the juice HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violation(s) of the Act and all applicable regulations.
Please send your reply to Food and Drug Administration, Attention:  Sheena Crutchfield, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Crutchfield via email at sheena.crutchfield@fda.hhs.gov. Please reference #501342 on any submissions and within the subject line of any emails to us. 
William A. Correll
Office of Compliance
Center for Food Safety
    and Applied Nutrition
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