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  5. Ital Lemon - 494240 - 05/16/2016
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Ital Lemon MARCS-CMS 494240 —

Recipient Name
Mr. Virginio Bersani
Ital Lemon

Via Filippo Turati, 2/4
Z.I. Mirandolina
26845 Codogno (Lodi)

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 


May 16, 2016
Mr. Virginia Bersani
General Manager
Ital Lemon S.P.A.
Via Filippo Turati, 2/4
Z.l. Mirandolina
Codogno (Lodi) 26845, Italy
Reference No. # 494240
Dear Mr. Bersani:
On December 3-4, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your juice processing facility, Via Filippo Turati, 2/4, Z.I. Mirandolina, Codogno (Lodi) 26845, Italy. 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, lnspectional 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 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 lemon and lime juice 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.
FDA acknowledges your written response to the FDA-483 sent via email on December 23, 2015. Your response included a response letter and other supporting HACCP documentation for your juice products, processing, pasteurization and supplier information. 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 hazard analysis and HACCP plan must include control measures that will consistently produce, at a minimum, a five-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, as required by 21 CFR 120.24(a). However, your firm's HACCP plan for 100% Lemon Juice and 100% Lime Juice products does not provide controls to ensure a 5-log reduction of the Listeria monocytogenes, E. coli, and Salmonella as pertinent microorganism(s) in your 100% lemon and lime juices.
Your manufacturing process includes several steps, (b)(4). During processing, there are opportunities for microbial contamination. The juice HACCP regulation, 21 CFR 120.24(c), states that the 5-log reduction should be performed on the final product packaging within a single production facility operating under good manufacturing practices. Therefore, the pasteurization process conducted by your supplier cannot be carried over and be used to justify the lack of 5-log reduction conducted at your facility where final packaging occurs.
Your written response states that the natural characteristics of the lemon juice inhibit all food pathogenic microorganisms and the product is stabilized by the addition of sulfites. Relying on the natural pH of lemon and lime juice to control pathogens is not adequate since pathogens such as E. coli 015:H7, Listeria monocytogenes, and Salmonella have been associated with illness in juices with a pH less than 4.6. Your response included a declaration from The Experimental Station for the Food Preserving Industry (SSICA), an Italian trade association, as well as a SSICA reference and microbial testing results. However, you will need to provide a validation study or other scientific support to demonstrate that the specific conditions used by your facility can achieve a 5-log reduction in the pertinent microorganisms. For example, the study or scientific documentation should support the specific acidity/pH, temperature, holding time, and/or concentrations of sulfites that are necessary to achieve a 5-log reduction.
Lastly, your HACCP plan for Lemon/Lime Juice lists a critical limit (b)(4) at the Receiving critical control point which does not provide control over "pathogenic germs" in the final product. As discussed above, you are required to perform a validated 5-log reduction of pertinent microorganisms in accordance with 21 CFR 120.24.
2.    Your hazard analysis and HACCP plan must, at a minimum, list all food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.7(a) and 120.8(b). However, your HACCP plan dated October 14, 2015, for your 100% Lemon Juice and 100% Lime Juice products does not include the food safety hazards of metal inclusion due to the (b)(4) and undeclared allergens or food intolerance substances.
With regard to the hazard of undeclared allergens or food intolerances, your 100% juice products contain potassium metabisu1fite, a sulfiting agent. Sulfites are known to cause intolerance reactions in sensitive individuals. Sensitive individuals can experience symptoms ranging from mild to life-threatening, including tingling sensations in the mouth, hives, digestive upset swelling of the tongue and throat, and difficulty in breathing. You must incorporate label control in your HACCP plan to ensure that sulfites are consistently declared on the label for all your products that contain sulfites.
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.
You should respond in writing within 15 working days from your receipt of this letter. Your response should include documentation reflecting the changes you made, such as a copy of your revised juice HACCP plan for lemon and lime juice products, the validation study demonstrating that you can achieve a five log reduction, updated label for your lemon and lime juice products, 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. 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.
lf 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 100% Lemon Juice and 100% Lime Juice products under Section 801(a) of the Act (21 U.S.C. § 381 (a)), including subjecting it to 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. 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/importalert _761.html
Please send your reply to the U.S. Food and Drug Administration, Attention: Rosemary Sexton, 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 #494240. You may send any questions you have regarding this letter to Ms. Sexton via email at rosemarv.sexton@fda.hhs.gov.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
    and Applied Nutrition

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