Inspections, Compliance, Enforcement, and Criminal Investigations
Ninth St. Management Inc. (Trades as Superior Pasta Co Inc.) 8/13/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
RETURN RECEIPT REQUESTED
August 13, 2009
Ms. Cheryl L. Lomanno, President
Ninth St. Management, Inc.
T/A Superior Pasta Co., Inc.
905 Christian Street
Philadelphia, PA 19147
Dear Ms. Lommanno:
We inspected your seafood processing facility, located at 905-909 Christian Street, Philadelphia, PA on March 24-30, 2009. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Points (RACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a RACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the fishery 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 crab ravioli, lobster ravioli, shrimp ravioli, lobster manicotti, shrimp manicotti, crab sauce, and clam sauce are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
In addition, after review of your product labels, we found that some of your products are misbranded within the meaning of sections 403 of the Act [21 U.S.C. 343] and Title 21, Code of Federal Regulations (CFR) Part 101. You may find the Act, the seafood RACCP regulation, food labeling regulations, and the Fish and Fisheries Products Hazards & Controls Guidance: 3r Edition (the Hazard Guide), through links in the FDA's home page at www.fda.gov.
Specifically, your significant seafood HACCP violations were as follows:
1. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring frequency of continuous monitoring at the refrigerated storage critical control point, as listed in your HACCP for Crab Ravioli to control the hazard of pathogen growth and toxin formation (including Clostridium botulinum).
2. You must conduct, or have conducted for you, a hazard analysis for each land 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). However, your firm does not have a HACCP plan for your frozen lobster manicotti, shrimp manicotti, crab sauce, and frozen clam sauce to control the food safety hazards of pathogen growth/toxin formation and undeclared food allergens. Additionally, the hazard analysis and HACCP plan for your crab ravioli parenthetically include shrimp and lobster ravioli as well. However, you must separately conduct a hazard analysis for each land of fish and fishery product to determine whether each product must be covered by a separate HACCP plan.
Your ravioli products, pasta products made with durum wheat flour, Porcini Mushroom Sauce, and Cheese Manicotti pieces are misbranded within the meaning of Section 403(w) of the Act [21 U.S.C. 343(w)] in that their labels fail to declare all major food allergens present in the products, as required by section 403(w)(1) of 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 certain exceptions, e.g., highly refined oils derived from a major food allergen. Further, a food is misbranded under section 403(w) of the Act 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:
i) 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 U.S.C. 343(w)(1)(A)], or
ii) 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. " flour (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)].
The products noted below are manufactured from ingredients that contain major food allergens, but the major food allergens are not listed on the finished product labels as required.
• Your ravioli products and Cheese Manicotti contain cheese (the Cheese Manicotti contains Ricotta and the ravioli products contain Ricotta and Romano) and butter, but fail to declare the presence of the allergenic ingredient, milk. Additionally, the pasta dough ingredient in these two products contains egg, but both products fail to declare the presence of the allergenic ingredient, egg.
• Your pasta products made with durum wheat flour list the ingredient "flour" in the ingredient statements, but fail to declare the allergenic ingredient, wheat.
• Your Porcini Mushroom Sauce lists the ingredients "cream" and "butter" in its ingredient statement, but fails to declare the allergenic ingredient, mille. Additionally, your Porcini Mushroom Sauce lists the ingredient "flour," but fails to declare the allergenic ingredient, wheat.
We also note that your lobster ravioli product is manufactured with cod oil, which is a component of codfish. As explained above, fish is a major food allergen and is therefore subject to the allergen source labeling requirements of the Food Allergen Labeling and Consumer Protection Act (FALCPA). Section 201(qq)(2)(A) of the Act provides an exemption for highly refined oils; therefore, highly refined cod oil would not be subject to the allergen source labeling requirements of Section 403(w). If the cod oil in your lobster ravioli is not highly refined, however, the product label must declare the presence of fish consistent with section 403(w) of the Act. It is your responsibility to determine whether or not the cod oil used in your products is highly refined. Additional information about allergen source labeling is available on our website at http://www.cfsan.fda.gov/~dms/wh-alrgy.html.
Your ravioli products and Cheese Manicotti pieces are misbranded under Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that they are fabricated from two or more ingredients, but their labels fail to bear the common or usual name of each ingredient. Specifically, the package for your Cheese Manicotti pieces does not bear a list of ingredients as required by 21 CFR 101.4. Additionally, the labels on your ravioli products fail to declare all subingredients (ingredients of an ingredient in a finished product) for the following ingredients, as required by 21 CFR 101.4(b)(2):
• Our investigation found that your ravioli products contain the ingredient durum wheat flour; however, the labels for your ravioli products fail to declare the subingredients of durum wheat flour as specified by 21 CFR 101.4(b)(2) and (b)(15).
• The ingredient statements for your ravioli products declare the standardized food Romano cheese (see 21 CFR 133.183), but fail to declare all of the subingredients in this standardized food.
• The ingredient statements for your ravioli products declare the ingredient Ricotta cheese, but fail to declare the subingredients of Ricotta cheese.
• The label for your lobster ravioli does not declare all of the sub-ingredients in the "lobster base" ingredient.
• Your lobster ravioli does not list the sub-ingredients in the "dough mix" ingredient.
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 multicomponent 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)].
Your ravioli products and Cheese Manicotti product are misbranded within the meaning of Section 403(e)(2) [21 USC 343(e)(2)] in that the packages for these products sold to individual customers do not bear the net quantity of contents in accordance with 21 CFR 101.105.
Your ravioli products are misbranded under section 403(i)(I) of the Act [21 U.S.C. 343(i)(l)] in that they fail to bear the common or usual name of the food, as required by 21 CFR 101.3. The packages for your ravioli products do not clearly identify the products as ravioli. For example, there is a square labeled "lobster" marked on the side of the lobster ravioli package, but the package does not specify that the product is ravioli.
Your sauces and Cheese Manicotti product are misbranded within the meaning of Section 403(e)(1) [21 USC 343(e)(1)] in that the packages do not bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
Additionally, your ravioli product labels fail to include a zip code as part of the address for the place of business, as required by 21 CFR 101.5(d).
You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.
Finally, we note that the labels for your cheese ravioli and lobster ravioli state "All Natural Ingredients" and then list the products' ingredients, some of which are synthetic. FDA considers use of the term "natural" on a food label to be truthful and nonmisleading only when the food contains no added color, artificial flavors, or synthetic substances.
This letter may not list all the violations at your facility and on your product labels. You are responsible for ensuring that your processing plant operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations, including the Good Manufacturing Practice regulations (21 CFR Part 110). You are also responsible for ensuring that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. In addition to consulting the Act and Title 21 of the CFR, you may find it useful to visit our website at http://www.cfsan.fda.gov when reviewing your labels.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific things that you are doing to correct the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
Your response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or LYllli.Bonner@fda.hhs.gov.
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, Assistant Director