Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch ParkwayCollege Park, MD 20740
December 10, 2015
VIA EXPRESS DELIVERY
Target Agriculture, Ltd.
P.O. Box 6
Sri Lanka 81700
Reference No. # 483362
Dear Mr. Gerbracht:
We inspected your juice processing facility, Target Agriculture located at Tanamera Estate, Ibbawala/Weligama, Sri Lanka, on June 9-10, 2015. During that inspection, we found you had serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm.
We acknowledge receipt of your response sent via email on July 15, 2015. Your response included a HACCP plan for your organic frozen graviola juice, photographs, and other supporting information. Our evaluation of your revised HACCP plan and the information you provided on your manufacturing process, revealed continuing concerns with your firm’s operations as further described 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 Part 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 [21 U.S.C. § 342 (a) (4)]. Accordingly, your frozen graviola juice 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.
Your significant deviations are as follows:
1. Your HACCP plan must, at a minimum, list the critical limits that must be met at each critical control point, to comply with 21 CFR 120.8(b)(3). A “critical limit” is defined in 21 CFR 120.3(e) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard.” However, your HACCP plan for organic frozen graviola juice lists the critical limit, “(b)(4)”, at the “Pasteurization” critical control point that is inadequate to control the food safety hazards of Salmonella and E. coli. Specifically, your critical limit does not include the processing time of the juice heat treatment. FDA recommends when using (b)(4), that you monitor both the time and temperature of the juice heat treatment as critical limits to ensure that your process is achieving a minimum 5-log pathogen reduction.
2. Your HACCP plan must, at a minimum, lists the procedures and their frequencies for each critical control point to ensure compliance with the critical limits, to comply with 21 CFR 120.8(b)(4). However, your HACCP plan for organic frozen graviola juice lists a monitoring procedure at the “Pasteurization” critical control point that is not adequate. Specifically, your monitoring procedure lists (b)(4). However, FDA recommends continuously monitoring both the time and temperature of the juice heat treatment using a temperature-recording device to ensure compliance with the critical limits.
3. Since you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 120.8(b)(5). However, your corrective action plan listed in your HACCP plan for organic frozen graviola juice is not appropriate. Specifically, your corrective action at the “Pasteurization” critical control point states you will “(b)(4).” However, you do not state how you will correct the cause of the deviation as required by 21 CFR 120.10(a).
4. You must adequately monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, compliance with current good manufacturing practices to comply with 21 CFR 120.6(b). However, your firm did not monitor the conditions and cleanliness of food contact surfaces; did not prevent cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces; and did not exclude pests from the food facility, as evidenced by:
a. Staining and food accumulation on strip curtains located between the “clean” and “dirty” sides of the facility, that come into direct contact with cut fruit as the fruit is passed through the window.
b. Visible mold growth on the side of production tables in the “dirty” side of the facility and covering wooden pieces, which has an overlay of metal constructed as a cutting surface.
c. Visible dirt accumulation on the sides of plastic crates used to store washed fruit.
d. Three (3) flies on food equipment in the “clean” production room. In addition, your fly trap was not functioning.
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 these deviations. 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 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 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 violations of the Act and all applicable regulations.
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. 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 consider providing a copy of this letter to your U.S. Agent.
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, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Crutchfield via email at firstname.lastname@example.org.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition