Inspections, Compliance, Enforcement, and Criminal Investigations
Springfield Pasta Company, Inc. 8/6/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
August 6, 2012
Robert J. Napoletano, Partner
Springfield Pasta Company, Inc.
186 Saxer Avenue
Springfield, PA 19064-2335
Dear Mr. Napoletano:
The U.S. Food and Drug Administration (FDA) inspected your processing facility located at 186 Saxer Avenue, Springfield, Pennsylvania, on May 2, 2012 through May 4, 2012. Our inspection found significant deviations from the food labeling regulations, Title 21, Code of Federal Regulations (21 CFR), Part 101. These violations cause your Frozen Potato Gnocchi, Frozen Cheese Gnocchi, Frozen Spinach and Cheese Ravioli, Angel Hair Pasta, Pure Egg Spaghetti, Egg Spaghettini and Pure Egg Fettuccine products distributed by your firm, to be misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 343. You may find the Act and the referenced CFR regulations through links on FDA’s home page at www.fda.gov.
Your list of significant violations include:
1. Your Frozen Potato Gnocchi and Frozen Cheese Gnocchi products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels for these products fail 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 Frozen Potato Gnocchi and Frozen Cheese Gnocchi product labels reveal that the ingredient Durum Wheat Flour is used in the products manufacture; however the product labels fail 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 Frozen Cheese Gnocchi product is misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), because it is fabricated from two or more ingredients but the labeling fails to bear a complete list of all of the ingredients by common or usual name in descending order of predominance by weight, as well as sub-ingredients, as required by 21 CFR 101.4. Specifically, your Frozen Cheese Gnocchi product contains Ricotta Cheese, which is a multi-ingredient food. However, the label does not declare the presence of the sub-ingredients in this multi-component food in accordance with 21 CFR 101.4(b)(2).
The requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food [21 CFR 101.4(b)(2)].
For additional information on General Food Labeling requirements go to http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm.
3. Your Frozen Potato Gnocchi, Frozen Cheese Gnocchi, Frozen Spinach and Cheese Ravioli and Angel Hair Pasta 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 in an appropriate format as defined within 21 CFR 101.9. For example:
• The labels for your Frozen Potato Gnocchi and Frozen Cheese Gnocchi products declare the serving size as “4 oz.” In accordance with 21 CFR 101.9(b)(7), a label statement regarding a serving shall be the serving size expressed in common household measure and shall be followed by the equivalent metric quantity in parenthesis. The reference amount customarily consumed per eating occasion for this product category (Pastas, plain) is 140g, prepared, according to 21 CFR 101.12(b) Table 2; therefore the product serving size for your product must be declared as “____cup(s) (___g)”.
In addition, because 4 ounces is different from 140g, and the appropriate household measure for this gnocchi is likely cups verses ounces, the amount of gnocchi in a cup or portion of a cup that is closest to 140g is likely to be different from the amount of gnocchi in 4 ounces which is specified on the label. This will result in different values for the nutrients in the Nutrition Facts panel.
• The labels for your Frozen Spinach and Cheese Ravioli, Frozen Cheese Gnocchi and Angel Hair Pasta fail to declare Trans fat on the nutrition facts information panel, as required by 21 CFR 101.9(c)(2)(ii).
• The labels for your Frozen Potato Gnocchi, Frozen Cheese Gnocchi and Angel Hair Pasta products fail to express “Cholesterol” to the nearest 5 mg increment, as required by 21 CFR 101.9(c)(3).
The violations mentioned in this letter are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to promptly correct these violations may result in legal action, without further notice, including, but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.
We also note the following comments:
• Your Pure Egg Spaghetti, Egg Spaghettini and Pure Egg Fettuccine products declare the allergen, wheat, exclusively on the principal display panel of the label. In accordance with section 201(qq) of the Act, [21 U.S.C. § 321(qq)] wheat is considered a major food allergen and must be declared in accordance with the requirements of 403(w) of the Act [21 U.S.C. § 343(w)].
• Your Frozen Cheese Gnocchi product label states, “IF CHEESE GNOCCHI-Ricotta Cheese Added,” thus Ricotta Cheese is used in the products manufacture; however the product label fails to declare the presence of the major food allergen, milk [403(w) 21 U.S.C. § 343(w)].
• The “Our Pledge” with signature statement is intervening material between the nutrition information and ingredient statement and the name and place of business on your Frozen Potato Gnocchi and Frozen Cheese Gnocchi products. Under 21 CFR 101.2(e), the ingredient list and certain other mandatory information is required to appear in one place without other intervening material.
• Your Spinach and Cheese Ravioli product is considered a mixed dish measurable with a cup. Consequently the serving size for this product appears to be incorrect. It declares a serving as three pieces (114 g), rather than a cup in accordance with 21 CFR 101.12(b) Table 2. Conversely, if the ravioli is particularly large (i.e., jumbo size) and does not fit easily into a cup, then the serving size is considered a mixed dish not measurable with a cup at 140 g. In that case four pieces would seem to be a more appropriate serving.
• The labels for your Potato Gnocchi and Cheese Gnocchi are different labels with different text for the name of the product on the PDP and different values for the nutrients found in the Nutrition Facts panel. Since they are separate labels and do not appear to be designated at the time of packaging as potato or cheese gnocchi, the ingredient label should be specific to the product. As a result, the ingredients should be listed in descending order by weight and not as in its current form “If Cheese Gnocchi...”
• Your Frozen Potato Gnocchi and Frozen Cheese Gnocchi products do not appear to meet the criteria for the tabular format when listing the Nutrition Facts information. In accordance with 21 CFR 101.9(j)(13)(ii), foods in packages that have a total surface area available to bear labeling of 40 or less square inches may modify their display and use a tabular format. Hence, the tabular format may be used only if there is not sufficient continuous space for the vertical format of the full, shortened, or simplified formats.
Please notify this office in writing within fifteen (15) working days of receiving this letter of the specific steps you are taking to correct the violations described above, and in particular, what methods and controls you will implement to prevent their recurrence. Please include copies of any documentation that demonstrates the corrections have been implemented. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, please state the reason for the delay and the time frame in which they will be completed.
Further, 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 domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic 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.
Your written response should be sent to Lynn S. Bonner, Compliance Officer, at the address noted above. If you have questions concerning this letter, please contact Compliance Officer Bonner at 215-717-3074 or by e-mail at Lynn.Bonner@fda.hhs.gov.
Kirk D. Sooter
Philadelphia District Office
Cc: Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Director