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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Distribucion Y Representaciones Comerciales S.A. 3/21/12


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

Public Health Service
Food and Drug Administration
 College Park, MD 


March 21, 2012
Mr. Remo Yaconi, Jr., Production Manager
Distribucion Y Representaciones Comerciales S.A.
Carlos Salas Herrera 3680
Conchali, Santiago, Chile
                      Reference No.: 284857
Dear Mr. Yaconi, Jr.:
The U.S. Food and Drug Administration (FDA) inspected your juice processing facility located at Fundo El Escudo S/N, Teno, Curico, Chile on November 14-15, 2011. During that inspection, we found that your firm had serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120, and the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Parts 120 & 110). In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of Part 120, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your 100% shelf-stable bottled juices products 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, the juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov
This inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the deviations found at your firm. Your firm’s significant deviations are as follows:
• You must develop, or have developed for you, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each type of juice that you process, and you must have and implement a written HACCP plan whenever that hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, to comply with 21 CFR Parts 120.7(a) and 120.8(a). However, your firm does not have a written hazard analysis or a written HACCP plan for your 100% shelf-stable bottled Apple Juice, Plum Juice, Quince Juice, and Grape Juice you manufactured and previously exported to the United States to control the hazards of pathogens, chemicals, heavy metals, patulin, pesticides, metal, and glass inclusion.  
Furthermore, you must include in your hazard analysis and HACCP plan control measures that will consistently produce, at a minimum a 5 log reduction of the pertinent microorganism for at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR Part 120.24(a). The "pertinent microorganism" is defined as "the most resistant microorganism of public health significance that is likely to occur in the juice," 21 CFR 120.24(a). 

• You must have and implement a sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing as required by 21 CFR 120.6(a). Specifically, your firm does not have an SSOP that monitors and controls the following eight key areas of sanitation:

o The safety of water that comes into contact with food or food contact surfaces or that is used to manufacture ice;

o The condition of cleanliness of food contact surfaces;

o The prevention of cross-contamination from insanitary objects;

o The maintenance of hand washing, hand sanitizing, and toilet facilities;

o The protection of food, food packaging material, and food contact surfaces from adulteration with contaminants;

o The proper labeling, storage, and use of toxic compounds;

o The control of employee health conditions that could result in microbiological contamination of the food packaging materials, and food contact surfaces; and,

o The exclusion of pests from the food plant. 

You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to further correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) 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 action to refuse admission of your imported 100% shelf-stable bottled 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 which can be found on FDA’s web site at: http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm.
This letter may not list all the violations at your facility. You are responsible for ensuring that you firm operates in compliance with the Act, the juice HACCP regulation (21 CFR Part 120), the CGMP regulation (21 CFR Part 110), and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
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. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the U. S. Food and Drug Administration, Attention:  Robyn R. Jones, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A.If you have any questions regarding any issue in this letter, you may contact Ms. Jones at (240) 402-2575 or via email at robyn.jones@fda.hhs.gov.
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety 
and Applied Nutrition