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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Lodato Gennaro & C S.p.A. 3/7/13

  

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
MAR 7, 2013
 
VIA EXPRESS DELIVERY
 
Mr. Lodato Gennaro, Quality Manager
Lodato Gennaro & C S.p.A.
Frazione Santa Maria A Fovore
Castel San Giorgio 84083
Italy
 
Re: 391860
 
Dear Mr. Gennaro:
 
We inspected your facility Lodato Gennaro & C S.p.A., located at Frazione Santa Maria A Fovore, Castel San Giorgio, 84083, Italy, on November 19th and 20th, 2012. The inspection was conducted to determine compliance with the Federal Food, Drug, and Cosmetic Act (the Act). During the inspection, FDA collected labels for several of your products. Based on our review, we have concluded that these products are adulterated and misbranded within the meaning of sections 402 and 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 342 and 343], and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find copies of the Act and FDA regulations through links in FDA’s home page at http://www.fda.gov.
 
Your significant labeling deviations are as follows:
 
1.    Your Annalisa Zuppa Di Farro product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the label fails to declare the known major food allergen, wheat, as specified by the Act. 
 
Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines as “major food allergens” milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:
 
  • The word “Contains,” followed by the name of the food source from which the major food allergen is derived, printed immediately after or adjacent to the list of ingredient, section 403 (w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or

 

  • The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g. “(wheat)”), except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act, [21 U.S.C. 343(w)(1)(B)].
 
Specifically, your Annalisa Zuppa Di Farro product is labeled to contain “spelt”, however, the product label fails to declare the presence of the major food allergen, wheat.
 
Further guidance and information on food allergens can be accessed on FDA’s website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.
 
2.    Your Annalisa Zuppa Di Orzo Perlato, Annalisa Zuppa Di Farro, Annalisa Zuppa Di Grano Saraceno, Annalisa Fagioli Tondini, Annalisa Grano Cotto (550 g and 400 g), Annalisa Peperoni Arrostiti, Annalisa Fagioli Cannellini (400 g), Annalisa Chick Peas, Annalisa Cannellini Beans (12.30 oz), Annalisa Tondini Beans, Annalisa Butter Beans, Annalisa Borlotti Beans, Annalisa Extra-Fine Peas, LaCastellina Borlotti Beans, LaCastellina Butter Beans, LaCastellina Check-Pea, LaCastellina White Beans, and Annalisa White Beans (92 oz) products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because the nutrition facts information is not presented in the proper format or with the proper content. Specifically:
 
  • For your Annalisa Zuppa Di Orzo Perlato, Annalisa Zuppa Di Farro, Annalisa Zuppa Di Grano Saraceno, Annalisa Fagioli Tondini, Annalisa Grano Cotto (550 g and 400 g), Annalisa Peperoni Arrostiti, and Annalisa Fagioli Cannellini (400 g) products:
    • The nutrition labels do not meet the formatting requirements of 21 CFR 101.9(d).
    • Many of the mandatory nutrients, such as cholesterol, sodium, and trans fat, are not declared as required by 21 CFR 101.9(c).
    • The nutrition labels fail to round the values for certain nutrients as specified by 21 CFR 101.9(c). For example, protein must be expressed to the nearest gram [21 CFR 101.9(c)(7)].
    • The serving size declarations are not expressed in a common household measure as required by 21 CFR 101.9(b)(5) and 21 CFR 101.12(b). 
  • For your Annalisa Chick Peas, Annalisa Cannellini Beans (12.30 oz), Annalisa Tondini Beans, Annalisa Butter Beans, Annalisa Borlotti Beans, Annalisa Extra-Fine Peas, LaCastellina Borlotti Beans, LaCastellina Butter Beans, LaCastellina Check-Pea, LaCastellina White Beans, and Annalisa White Beans (92 oz) products:
    • A percent DV cannot be provided for trans fat in accordance with 21 CFR 101.9(d)(7)(ii) because there is no established daily value for trans fat.
    • The nutrition label fails to round the values for certain nutrients as specified by 21 CFR 101.9(c). For example, sodium must be expressed to the nearest 10-milligram increment when the serving contains greater than 140 mg [21 CFR 101.9(c)(4)]

3.    Your Annalisa Zuppa Di Orzo Perlato, Annalisa Zuppa Di Farro, and Annalisa Zuppa Di Grano Saraceno products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product labels contain information in two languages, but do not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Your labels do not appear to provide a statement of identity in English on the principal display panel, as per 21 CFR 101.3(a).

4.    Your Annalisa White Beans, la Castellina Borlotti Beans, la Castellina Butter Beans, and la Castellina White Beans products are misbranded within the meaning of section 403(i) of the Act [21 U.S.C § 343(i)] because the labels fail to bear the common or usual name of the food or each ingredient. For example:
 
    • Your Annalisa White Beans, la Castellina Borlotti Beans, la Castellina Butter Beans, and la Castellina White Beans labels fail to properly designate ingredients as required by 21 CFR 101.4. The ingredients statements state “beans” rather than the specific type of bean contained in the product (i.e. borlotti beans, butter beans, or cannellini beans). According to 21 CFR 101.4(b), the name of an ingredient shall be a specific name and not a collective (generic) name.
 
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 Good Manufacturing Practice regulation (21 CFR 110) and labeling regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation, such as a copy of any revised labels, and any other useful information that would assist us in evaluating your corrections.   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 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. 
 
We also note the following labeling comments:
 
  • Your Annalisa Zuppa Di Orzo Perlato, Annalisa Zuppa Di Farro, Annalisa Zuppa Di Grano Saraceno, Annalisa Fagioli Tondini, Annalisa Grano Cotto (550 g and 400 g), Annalisa Peperoni Arrostiti, Annalisa Fagioli Cannellini (400 g), and Annalisa White Beans (92 oz) product labels fail to bear an accurate statement of the net quantity of contents in accordance with 21 CFR 101.105. Specifically:

 

    • For your Annalisa Zuppa Di Orzo Perlato, Annalisa Zuppa Di Farro, Annalisa Zuppa Di Grano Saraceno, Annalisa Fagioli Tondini, Annalisa Grano Cotto (550 g and 400 g), Annalisa Peperoni Arrostiti, and Annalisa Fagioli Cannellini (400 g) products:
    • The net quantity of contents is not declared in terms of weight designated in U.S. customary terms (21 CFR 101.105).
    • The net quantity of contents is not declared on the principal display panel in accordance with 21 CFR 101.105(a).
    • Your Annalisa White Beans (92 oz) product includes the net weight of 92 oz. The net quantity of contents declaration for packages containing 4 pounds or more and labeled in terms of weight must be expressed in pounds for weight units with any remainder in terms of ounces or common or decimal fraction of the pound, e.g., “92 oz (5 lbs 12 oz)” in accordance with 21 CFR 101.105(k).
  • Your Annalisa Fagioli Tondini, Annalisa Grano Cotto (550 g and 400 g), Annalisa Peperoni Arrostiti, and Annalisa Fagioli Cannellini (400 g) products bear Italian and English statement of identities on the information panel; however, the statement of identity is required to be in both languages on the principal display panel. If a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language, in addition to the required English language. 
  • Your Annalisa White Beans and la Castellina White Beans labels bear the statement of identity “White Beans.” “White beans” is a generic name that may apply to several types of beans such as navy beans, great northern beans, cannellini beans, white kidney beans, pea beans, or marrow beans and may not enable a consumer to distinguish it from different foods. If you consistently use a specific type of bean in the manufacturing of this product, we recommend the statement of identity specify the type of white bean used in the product.
 
We also note the following comments regarding the Good Manufacturing Practice regulation (21 CFR 110):
 
  • Water hoses located inside and outside of your facility were not equipped with backflow prevention devices. Many of the hoses were observed lying on the ground. Eight soaking tanks, where beans are soaked overnight, had water inlets inside the tanks that were at or below the overflow level of the tanks, which does not allow for proper backflow prevention to prevent contamination of the water supply. Please be aware that 21 CFR 110.37(b)(5) requires you to provide there is no backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing.
  • Your chutes, diverts, and de-stoners were not smoothly bonded and provided crevices for accumulation of organic matter. Please be aware that 21 CFR 110.40(b) requires you to have smoothly bonded or maintained seams on food-contact surfaces so as to minimize accumulation of food particles and organic matter and thus minimizing the opportunity for growth of microorganisms.
 
Please send your reply to Lara Snyder, Consumer Safety Officer, Food and Drug Administration, Office of Compliance, Division of Enforcement, Labeling and Dietary Supplement Compliance Team (HFS-608), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Snyder via email at lara.snyder@fda.hhs.gov.
 
Sincerely,
/S/
Roberta Wagner
Director
Office of Compliance
Center for Food Safety
   and Applied Nutrition