Inspections, Compliance, Enforcement, and Criminal Investigations

SkyPeople Juice Group Co., Ltd 5/4/16

  

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

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

 

WARNING LETTER
MAY 4, 2016 
 
VIA EXPRESS DELIVERY
 
 Xue Hongke, General Manager
SkyPeople Juice Group Co., Ltd.
16F, China Development Bank Tower
No. 2 Gaoxin Road
Xian, Shaanxi, China 710075
 
 
Reference No. # 494313
 
Dear Mr. Hongke:
 
On December 3-4, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your juice processing facility, SkyPeople Juice Group Co., Ltd., located at Sanxu Village, Sanqu County, Jinyang County, Xian, Shaanxi, China. The inspection revealed serious deviations from the FDA's juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120  (21 CFR 120). This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA- 483), at the conclusion of the inspection which listed the deviations found at your firm.
 
In accordance with 21 CFR Part 120.9, failure of a processor to implement a HACCP plan that complies with the requirements of 21 CFR 120, renders the juice products adulterated within the meaning of the Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) [U.S.C. § 342(a)(4)]. Accordingly, your apple and pear juice concentrate are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, FDA’s juice HACCP regulations, and the Juice HACCP Hazards and Controls Guidance through links in FDA’s home page at www.fda.gov.
 
We acknowledge receipt of your response to the FDA-483 sent via email on December 24, 2015 and your revised HACCP plan sent via email on February 16, 2016.  Your response included various documents, including a response letter and other supporting documentation. However, our review of the documentation revealed that your response is inadequate, as further described in this letter.
 
We found the following significant deviations:
 
1.    Your HACCP plan must, at a minimum, lists 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 firm's revised HACCP plans for “Pear Juice Concentrate, Apple Juice Concentrate” and “Deionized pear juice concentrate, Deionized apple juice concentrate” dated January 20, 2016, do not identify the food safety hazard of patulin associated with your apples at the “Receiving raw pear or apple” critical control point.  FDA recommends that apple processors obtain supplier guarantees at receiving (i.e., at your “Receiving raw pear or apple critical control point”) for each shipment of incoming fruit specifying that only apples harvested to exclude fallen apples were supplied in the shipment.
 
2.    Your HACCP plan must list the critical limits that must be met, to comply with 21 CFR 120.8(b)(3).  However, your firm's revised HACCP plans dated January 20, 2016 for “Pear Juice Concentrate, Apple Juice Concentrate” and “Deionized pear juice concentrate, Deionized apple juice concentrate” each list a critical limit at “Sorting of raw pear or apple (CCP2)” that is not adequate to control the hazard of patulin associated with the apples.  Specifically, your listed critical limit that allows for a (b)(4) of rotten fruit is inadequate. FDA recommends culling or trimming all defective apples to control patulin.
 
The above-identified deviations are not intended to be an all-inclusive list of deficiencies at your food manufacturing facility. It is your responsibility to ensure that your firm is in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct the current deviations. Your failure to promptly correct these deviations may result in administrative and/or regulatory action without further notice. 
 
Additionally, Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved.  Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).  For a foreign facility, FDA will assess and collect fees for re-inspection related costs from the U.S. Agent for the foreign facility.  Please consider providing a copy of this letter to your U.S. Agent.
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, 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 juice HACCP regulation. 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 violations.
 
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 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 processing regulations (21 CFR 120) is Import Alert #20-06. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
 
Please send your reply to the U. S. Food and Drug Administration, Attention: Stephanie Pogue, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A.  Please identify your response with CMS #494313. You may send any questions you may have regarding this letter to Ms. Pogue via email at Stephanie.Pogue@fda.hhs.gov.
 
 
 
Sincerely,
/S/
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
   and Applied Nutrition

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