Inspections, Compliance, Enforcement, and Criminal Investigations
Nonna's Real Italiana Cuccine 2/27/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New Orleans District
404 BNA Drive
Building 200, Suite 500
Nashville, TN 37217-1003
February 27, 2009
WARNING LETTER NO. 2009-NOL-05
DELIVERY SIGNATURE REQUESTED
Ruby H. Lovecchio, Owner
Nonna's Real Italiana Cuccine
1521 Nursery Avenue
Metairie, Louisiana 70005
Dear Ms. Lovecchio:
On October 15, 16, and 21, 2008, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your facility, located at 400 Pontchartrain Drive, Slidell, Louisiana. During the inspection, our investigator documented serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this Section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act(the Act) [21 United States Code (USC), Section 342(a)(4)]. Accordingly, your seafood-containing products ("Seafood Gumbo," "Crab and Corn Bisque," "Stuffed Crab," "Stuffed Mushrooms," and "Oyster and Artichoke Soup") are adulterated because 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 seafood HACCP regulation, and the Fish and Fisheries Products Hazards &Controls Guidance through links on FDA's Internet home page at www.fda.gov.
In addition, after careful review of your product labels, we found your "Stuffed Artichoke" and "Stuffed Mushrooms"products to be misbranded under Section 403 of the Act [21 USC 343]. Regulations implementing labeling requirements of the Act are found in 21 CFR 101 and 102.
Your significant violations were as follows:
1. You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product you produce to determine whether there are food safety hazards reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). You do not have HACCP plans for "Seafood Gumbo," "Crab and Corn Bisque," "Stuffed Crab," "Stuffed Mushrooms" (which contain crab meat), and "Oyster and Artichoke Soup" to control the food safety hazards of pathogen growth, potential toxin formation, and sulfites.
2. You must maintain sanitation control records which, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, you do not maintain sanitation monitoring records for the: 1) safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice; 2) condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; 3) prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product; 4) maintenance of hand washing, hand sanitizing, and toilet facilities; 5) protection of food, food packaging material, and food contact surfaces, from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants; 6) proper labeling, storage, and use of toxic compounds; 7) control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and, 8) exclusion of pests from the food plant.
1. Based on information you provided during the investigation, we estimate your firm sold approximately (b)(4) units of "Stuffed Artichoke" product in the last 12 months; therefore, it is not currently exempt under Section 403(q)(5) of the Act [21 USC 343(q)(5)] from the nutrition labeling requirements set forth in Section 403(q)(1) of the Act [21 USC343(q)(1)]. As a result, your "Stuffed Artichoke" product is misbranded within the meaning of Section 403(q)(1) of the Act [21 USC 343(q)(1)] because the label fails to bear nutrition labeling, as required by 21 CFR 101.9.
You may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review the nutrition labeling exemptions in 21 CFR 101.9(j)(18) [or see [http://www.cfsan.fda.gov/~dms/sbnle.html] for information on filing for an annual exemption. The application may be submitted online at: https://info l.cfsan.fda.gov/nle/client/login.cfm.
A hard copy of the Small Business Nutrition Labeling Exemption instructions and a blank application form are also enclosed.
2. Your "Stuffed Artichoke" product is misbranded within the meaning of Section 403(w) of the Act [21 USC 343(w)] because the label fails to declare all major food allergens present in the product, as required by Section 403(w)(1) of the Act [21 USC 343(w)(1)]. Section 201(qq) of the Act [21 USC321(qq)] defines as "major food allergens": milk, egg, fish, Crustacean shellfish, tree nuts; wheat, peanuts, and soybeans; as well as any food ingredient containing proteins 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 bearing or containing, 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, is printed immediately after or adjacent to the list of ingredients [Section 403(w)(1)(A) of the Act; 21 USC343(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, except 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 appearing 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 USC 343(w)(1)(B)].
Specifically, your "Stuffed Artichoke" product is made in part with (b)(4)" which contains whole wheat flour, wheat gluten, and soy flour. Your "Stuffed Artichoke" product, fails to declare the presence of the major food allergen "wheat" on its label. In addition, the only "soy" ingredient declared on your "Stuffed Artichoke" label is "partially hydrogenated vegetable shortening containing soybean and/or cottonseed [sic] oil." If the soybean oil in the product is highly refined, it is not a "major food allergen." In such a case, the product also violates Section 403(w) of the Act [21 USC 343(w)] because it contains soy flour, but fails to declare the presence of the major food allergen "soy" on its label.
3. Your "Stuffed Artichoke" and "Stuffed Mushrooms" products are misbranded within the meaning of Section 403(i)(2) of the Act [21 USC 343(i)(2)] as they are fabricated from two or more ingredients, but the labels fail to declare the common or usual name of each ingredient in the product, as required by 21 CFR 101.4. Specifically, both products are manufactured in part with (b)(4)", but fail to declare all of the sub-ingredients of the bread crumbs, as required by 21 CFR 101.4(b)(2).
The bread crumb ingredients not declared on the label of the "Stuffed Mushrooms" product include niacin, ferrous sulfate, folic acid, high fructose corn syrup, corn syrup, partially hydrogenated vegetable oil (cottonseed, corn, and/or canola oils), brown sugar, honey, molasses, whey, soy flour, whole wheat flour, rye flour, corn flour, oat bran, corn meal, rice flour, potato flour, dough conditioners (mono-and diglycerides, sodium and/or calcium stearoyl lactylate, soy lecithin, calcium carbonate), monocalcium phosphate, distilled vinegar, skim milk, buttermilk, lactic acid, calcium propionate, potassium sorbate, sesame seeds, spices, and parsley.
The bread crumb ingredients not declared on the label of the "Stuffed Artichoke" product include malted barley, thiamine mononitrate, folic acid, high fructose corn syrup, partially hydrogenated vegetable oil (corn and/or canola oils), brown sugar, honey, molasses, wheat gluten, whey, soy flour, whole wheat flour, rye flour, corn flour, oat bran, corn meal, rice flour, potato flour, butter, dough conditioners (mono-and diglycerides, sodium and/or calcium stearoyl lactylate, soy lecithin, calcium carbonate), yeast nutrients (ammonium sulfate, calcium sulfate, monocalcium phosphate), distilled vinegar, skim milk, buttermilk, lactic acid, potassium sorbate, and sesame seeds.
Both products also fail to declare all ingredients in the order required by 21 CFR 101.4(a)(1), 101.4(a)(2), and 101.4(b)(2).
4. Your "Stuffed Mushrooms" product is misbranded under Section 403(e)(1) of the Act [21 USC 343(e)(1)] as the label does not include the place of business of the product manufacturer, packer, or distributor.
This letter is not intended to be a comprehensive list of deficiencies at your facility. It is your responsibility to ensure your facility operates in compliance with the Act and all applicable federal regulations.
You should take prompt action to correct these violations, and you should establish procedures to ensure such violations do not recur. Failure to do so may result in regulatory action without further notice, including seizure and/or injunction.
You should notify this office in writing, within 15 working days from receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence. You should include in your response documentation, such as copies of HACCP plans and monitoring records, copies of registration documents, and other useful information, to assist us in evaluating your corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Please address your reply to Rebecca A. Asente, Compliance Officer, at the address above. If you have questions regarding the contents of this letter, please contact Ms. Asente at (504) 219-8818, extension 104.
Carol S. Sanchez
Acting District Director
New Orleans District
Form FDA 483, dated October 21, 2008
Small Business Nutrition Labeling Exemption Instructions and Form