Inspections, Compliance, Enforcement, and Criminal Investigations
Dabruzzi's Italian Foods, Inc. 17-Nov-08
Department of Health and Human Services
Public Health Service
Minneapolis District Office
November 17, 2008
RETURN RECEIPT REQUESTED
Refer to MIN 09 - 04
Sharon A. Horne-Ellstrom
Dabruzzi's Italian Foods, Inc.
P.O. Box 209
Hudson, Wisconsin 54016-1509
Dear Ms. Horne-Ellstrom:
An inspection of your facility located at 417 Second Street, Hudson, Wisconsin, was conducted by an investigator from the Food and Drug Administration (FDA) on July 22 and August 5, 2008. This inspection verified that your firm manufactures and distributes pasta, sauce, and garlic bread products. During the inspection, we collected label samples of your Italian Garlic Butter Bread (20 oz), White Sauce (50 lbs), Red Sauce (1 lb), Manicotti, and Ravioli and Cheese. Based on our review of your product labels and other evidence obtained during the inspection, these products are misbranded within the meaning of section 403 of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 343]. Regulations implementing the food labeling requirements of the Act are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
The labeling violations are as follows:
1. Your Manicotti and Ravioli and Cheese products 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 the presence of the major food allergen wheat, as required by section 403(w)(1) of the Act. Specifically, the manicotti and ravioli products are manufactured using [(b)(4)] FLOUR" which contains wheat flour. However, the labels on these products fail to declare the presence of the allergenic ingredient, wheat. Similarly, the Italian Garlic Butter Bread products are misbranded under section 403(w) of the Act because they contain the ingredient "butter" in the ingredient statement, but fail to declare the presence of the allergenic ingredient, milk, 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:
• 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
• 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)].
2. Your Manicotti, White Sauce, and Red Sauce products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients and fail to bear the common or usual name of each such ingredient. Specifically, the labels on these products fail to list all sub-ingredients (ingredients of an ingredient in the finished product), as required by 21 CFR 101.4(b)(2). For example, according to their labels, your Red Sauce product contains the standardized food "parmesan cheese" and your White Sauce and Manicotti products contain the standardized foods "parmesan cheese" and "romano cheese" (see 21 CFR 133.165 and 133.183, respectively); however, your labels fail to declare all of the sub-ingredients of these ingredients on the finished product labels.
3. Your Ravioli and Cheese, Italian Garlic Butter Bread, White Sauce, Red Sauce and Manicotti products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] for nutrition information violations. For example,
• Your products fail to declare trans fat as required by 21 CFR 101.9(c)(2)(ii).
• Your Manicotti product fails to declare saturated fat, dietary fiber, sugars, and required vitamins and minerals as required by 21 CFR 101.9(c)(2)(i), 101.9(c)(6)(i), 101.9(c)(6)(ii), and 101.9(c)(8), respectively.
• Your Manicotti product fails to contain a serving size, and your White Sauce product fails to properly declare its serving size as required by 21 CFR 101.9(b) and 101.12(b). Specifically, serving sizes are determined based on the Reference Amounts Customarily Consumed (RACC), which are provided by 21 CFR 101.12(b). Your White Sauce product declares the serving size as "1/2 cup," but based on the RACC for "Minor main entree sauces (e.g., white sauce)," the serving size is "1/4 cup."
• Furthermore, the Nutrition Facts panel on your products fail to meet many of the rounding and formatting requirements specified under 101.9(c) and (d), e.g., rounding nutrients to the appropriate figures, using hairlines to set off the Nutrition Facts panel and to separate nutrients, and using the correct format to display nutrition information.
4. Your Manicotti and Ravioli and Cheese products are misbranded within the meaning of section 403(e)(2) for failing to contain an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Specifically, your Manicotti and Ravioli and Cheese, products failed to display any statement of net quantity (see 21 CFR 101.105).
Additionally, the Food and Drug Administration has determined that your facility is subject to the registration requirement in § 415 of the Act, 21 U.S.C. § 350d, and our implementing regulation at 21 CFR Part 1, Subpart H. During our inspection of your facility, you or your representative was advised of this requirement. The failure to register a facility as required is a prohibited act under § 301(dd) of the Act, 21 U.S.C. §331(dd). Our records indicate that, to date, this facility has not been registered with FDA.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, must register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or (301) 575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
This letter is not intended to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all products distributed by your firm are in compliance with the Act and its implementing regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice. These actions include, but are not limited to, seizure and injunction.
In addition to the violations described above, we have the following additional comment about your product labels. Your products fail to include a zip code on the labels as part of the place of business address. Under 21 CFR 101.5(d), the statement of the place of business must include the zip code, unless subject to certain exceptions.
You should notify this office in writing within 15 working days of receipt of this letter of each step that has been or will be taken to completely correct the current violations and to prevent the recurrence of similar violations, the time within which correction will be completed, and any documentation necessary to show that the correction has been achieved. 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.
Your reply should be sent to the attention of Compliance Officer Jane E. Nelson at the address on the letterhead.
JEN / ccl