Inspections, Compliance, Enforcement, and Criminal Investigations
Dante Confections 10/5/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District
October 5, 2011
VIA UPS OVERNIGHT MAIL
Santini Falcone, Co-owner
199 Boston Post Road
North Billerica, Massachusetts 01821
Dear Mr. Falcone:
The U.S. Food and Drug Administration (FDA) inspected your food manufacturing facility, located at 199 Boston Post Road, North Billerica, Massachusetts, on May 26, 27, June 6 and 7, 2011. Our investigation found serious violations of the Current Good Manufacturing Practice (CGMP) regulation in manufacturing, packing, or holding of human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the assorted truffles manufactured in your facility to be 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)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. Additionally, during the inspection copies of your labeling were collected. Our review of your labeling revealed that your firm's products are not labeled in accordance with FDA's food labeling regulation, 21 CFR Part 101. These violations cause your Peanut Butter Truffle, Peanut Butter Cups, and Nut Oyster products to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. You can find the Act and its implementing regulations through links on FDA's home page at http://www.fda.gov.
Your significant violations are as follows:
1. Your firm failed to take all reasonable precautions to ensure that production procedures do not contribute to contamination from any source. Therefore, equipment, containers, and utensils used to convey, hold or store raw rework materials, work-in process, rework or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). Specifically:
• Excess chocolate used to manufacture assorted truffles, including peanut butter filled truffles, was placed into a common chocolate tempering pot to be reworked and was used in the production of assorted truffle shells, fillings, and decorations, including non-nut filled truffles.
• Uncovered assorted truffles, not intended to contain nuts, were stored next to assorted products intended to contain nuts.
• You did not differentiate between cloth pastry bags used to fill the truffles with nut fillings versus non-nut fillings or between molds used to form nut free truffles and truffles containing peanut butter.
2. Your firm failed to clean the food contact surfaces of your manufacturing equipment as frequently as necessary, as required by 21 CFR Part 110.35(d). Specifically:
• The plastic truffle molds were used to make assorted truffles, including peanut butter and milk chocolate flavors. The truffle molds were caked with material and were not cleaned during your weekly cleaning process. Furthermore, you stated that truffle molds are cleaned approximately every 90 days.
We acknowledge your response to the FDA 483 dated June 7, 2011; however, it is inadequate because you fail to state how you are going to clean and sanitize your equipment. It is also unclear if you plan to properly clean your tempering pots. In addition, please provide a more detailed explanation about how you will prevent your production procedures from contributing to the possibility of cross contamination of non-nut containing products with nut containing products.
1. Your Peanut Butter Truffle, Peanut Butter Cups and Nut Oyster products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)) in that the major food allergens, milk, soy, tree nuts, and peanuts, are not declared on the product label as specified by the Act.
Section 201 (qq) of the Act [21 U.S.C. § 321 (qq)] defines 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, as "major food allergens." 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, 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 Peanut Butter Truffle, Peanut Butter Cups and Nut Oyster products are misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but fail to bear labels that list the common or usual name of each ingredient in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4. The requirement to list sub-ingredients (or component ingredients) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient (21 CFR 101.4(b)(2)(i)), or by listing the component ingredients without listing the ingredient itself (21 CFR 101.4(b)(2)(ii)). 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.
This letter may not list all the violations at your establishment. You are reminded that it is your responsibility to ensure that your firm operates in compliance with the Act, the regulations for Current Good Manufacturing Practices (21 CFR Part 110) and Food Labeling (21 CFR Part 101), and all other applicable implementing regulations. You should take prompt action to correct these violations and to implement procedures to prevent such violations from recurring. Failure to do so may result in regulatory action without further notice, including seizure and/or injunction.
In addition, we note that the net quantity content for your peanut butter truffle minis is in pieces. Under 21 CFR 101.105(c), when a declaration of the quantity of contents by numerical count does not give adequate information as to the quantity of the food in the package, the count must be accompanied by a statement of weight, measure or the size of the individual units as will provide such information.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Bruce R. Ota, Compliance Officer at the above address. If you have questions regarding any issues in this letter, please contact Mr. Ota at 781-596-7762.
Mutahar S. Shamsi
New England District