Inspections, Compliance, Enforcement, and Criminal Investigations
Vaccaro's Italian Pastry Shop, Inc. 5/7/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Baltimore District Office
6000 Metro Drive. Suite 101
Baltimore. MD 21215-3215
Telephone: (410) 779-5454
May 7, 2009
RETURN RECEIPT REOUESTED
Ms. Maria R. Vaccaro, Co-Owner
Vaccaro's Italian Pastry Shop, Inc.
3705 East Baltimore Street
Baltimore, MD 21224-1509
Dear Ms. Vaccaro:
The U.S. Food and Drug Administration (FDA) inspected your facility located at 3705 East Baltimore Street, Baltimore, Maryland, January 13 - 21, 2009, and verified that your firm manufactures and distributes bakery products. Our review of your product labels and other evidence collected during the inspection has determined that your 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 Part 101). Our investigators also documented violations of the Current Good Manufacturing Practices (CGMPs) regulations in 21 CFR Part 110 that cause the products manufactured in your facility to be adulterated within the meaning of Section 402(a)(4) of 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 become contaminated with filth, or may have been rendered injurious to health.
Violations of Current Good Manufacturing Practices Regulations:
1. You must use sanitizing agents that shall be adequate and safe under conditions of use. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and provide adequate cleaning and sanitizing treatment [21 CFR 110.35(d)(5»). However, to sanitize manufacturing equipment and utensils, your employees use a mixture of bleach and water, for which you have not determined whether the concentration of the bleach solution is adequate and safe.
2. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must wear, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints [21 CFR 110.10(b)(6)]. However, on January 13, 2009, an FDA inspector observed an employee who was not wearing a hair net or other head covering while handling cookie dough in the, processing area.
3. Clothing or other personal belongings must be stored in areas other than where food is exposed or where equipment or utensils are washed [21 CFR 110.10(b)(7)]. However, on January 13, 2009, an FDA inspector observed two half empty drink bottles underneath a table where cookies are manufactured, and a half-eaten cookie on top of a piece of manufacturing equipment in the processing room
1. Your Vaccaro's cannoli shell product sold to wholesale customers and your cannoli cream and cannoli shell products sold to individual customers are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] because the label fails to declare the presence of food allergens. Specifically, your labeled shipping carton for your cannoli shell product sold to wholesale customers fails to declare wheat. For your products sold to individual customers, there is no declaration of milk in your cannoli cream product and no declaration of wheat in your cannoli shell product.
Section 201 (qq) of the Act [21 U.S.C.§ 32l(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:
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)].
2. Your Vaccaro's cannoli cream and cannoli shell product sold to individual customers is misbranded within the meaning of403(q) of the Act [21 U.S.C. 343(q)] in the label fails to bear Nutrition Facts labeling, as required under 21 CFR 101.9
3. Your Vaccaro's cannoli cream and cannoli shell products sold to individual customers are misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(l)] because there is no statement of identity on the Principal Display Panel, as required under 21 CFR 101.3.
4. Your Vaccaro's cannoli shell and cannoli cream products sold to individual and wholesale customers 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 the labels fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. For example:
• There is no listing of ingredients on your Vaccaro's cannoli cream and cannoli shell products sold to individual customers.
• The label for your Vaccaro's cannoli shell product sold to wholesale customers declares "Vegetable Shortening"; however, this is not a proper common or usual name of this ingredient [21 CFR 101.4(b)(14)]. Each individual fat and or oil ingredient of a food intended for human consumption must be declared by its specific common or usual name (e.g. "beef fat," "cottonseed oil") in its order of predominance in the food, except that blends of fats and/or oils may be designated in their order of predominance in the foods as "__ shortening" or "blend of oils," the blank to be filled in with the word "vegetable," "animal," "marine," or combination of these, whichever is applicable if, immediately following the term, the common or usual name of each individual vegetable, animal, or marine fat or oil is given in parentheses, e.g., "vegetable oil shortening (soybean and cottonseed oil)."
• The label for your Vaccaro's cannoli cream product sold to wholesale customers lists "chocolate chip drop" and "ricotta cheese" as ingredients, but does not list the sub-ingredients of these ingredients.
5. Your Vaccaro's cannoli cream and cannoli shell products sold to individual customers are misbranded within the meaning of Section 403(e)(2) [21 U.S.C. 343(e)(2)] in that the outer containers for your cannoli cream and cannoli shell products sold to individual customers do not provide the net quantity of contents, as required under 21 CFR 101.105.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter may be symptomatic of serious problems in your firm's current good manufacturing practices. You should investigate and determine the causes of the violations; and take prompt actions to correct the violations and to bring your products into compliance.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please direct your response to: Randy F. Pack, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101 Baltimore, MD 21215. If you have any questions, please contact Mr. Pack at (410) 779-5417.