Inspections, Compliance, Enforcement, and Criminal Investigations
Petruzzi Pizza Mfg Inc 8/13/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
RETURN RECEIPT REQUESTED
August 13, 2012
Derek P. Zukovich, President
Petruzzi Pizza Mfg, Inc.
138 W. 21st Street
Hazleton, PA 18201-1909
Dear Mr. Zukovich:
The U.S. Food and Drug Administration (FDA) inspected your processing facility, located at 138 W. 21st Street, Hazleton, PA on May 22, 2012 through May 24, 2012. Our inspection found significant deviations from the Current Good Manufacturing Practice (cGMP) regulations for food manufacturers, Title 21, Code of Federal Regulations, (21 CFR), Part 110. These violations cause the foods manufactured and distributed by 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 were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Additionally, our inspection found significant deviations from the food labeling regulations, 21 CFR, Part 101. These violations cause the foods, distributed by your facility, to be misbranded within the meaning of section 403 of the Act [21 U.S.C § 343], in that they are not labeled with the mandatory information required by the Act. You may find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
Your significant cGMP violations are as follows:
1. Your firm failed to provide food handlers appropriate training in proper food handling techniques and food-protection principles to provide a level of competency necessary for production of clean and safe food [21 CFR 110.10(c)]. Specifically, on May 22, 2012, during the manufacture of (b)(4) brand Deli Pizza our investigator observed:
- An employee dropping a towel on the floor, which was previously on a food contact surface next to product. The employee picked up the towel and re-used it on the food contact surface.
- An employee dropping a knife on the floor, the knife was accidentally stepped on, and the employee picked the knife up off the floor and returned it to the food contact surface.
2. Your firm failed to maintain equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing, as necessary to protect against contamination of food [21 CFR 110.80(b)(1)]. Specifically, on May 22, 2012, during the manufacturing of (b)(4) brand pizza shells, our investigator observed that:
- There was unpackaged finished product on the conveyor system track on line (b)(4) being transported from the oven to the packaging area. The conveyor system was heavily soiled with a black and brown residue, which was coming in direct contact with the unpackaged finished product. Your firm failed to adequately clean and sanitize this equipment at a frequency that would protect against contamination of food.
- The pans used to bake the 12” and the 7” shells, were heavily soiled with a black residue and were not adequately cleaned before use.
- The clear plastic water supply line, used to spray the pizza shells on line (b)(4) with a (b)(4), prior to packaging, was soiled with an unknown brown substance.
3. Your firm failed to maintain equipment, containers and utensils used to convey food in a manner that protects against contamination [21 CFR 110.80(b)(7)]. Specifically, on May 22, 2012, our investigator observed that at the end of Line (b)(4) conveyor system, prior to the packaging area, the ramp descending onto the packaging table is covered in cardboard and plastic tape. This ramp is approximately five (5) feet in length and is not an acceptable food contact surface, in that it cannot be easily cleaned. Further, your unpackaged finished product comes in direct contact with this ramp.
4. Your employees failed to wash hand thoroughly in an adequate hand-washing facility before starting work to protect against the contamination of food [21 CFR 110.10(b)(3)]. Specifically, on May 22, 2012, during the manufacture of (b)(4) brand Deli Pizza, our investigator observed an employee enter the manufacturing area, and handle the product without washing his hands and use protective gloves.
5. Your employees failed to use gloves in food handling that are maintained in an intact, clean, and sanitary condition to protect against the contamination of food [21 CFR 110.10(b)(5)]. Specifically, on May 22, 2012, during the manufacture of (b)(4) brand Deli Pizza, our investigator observed one of your employee’s pick up items from the floor while wearing food contact gloves. The same employee then continued to handle food products, utensils, and food contact surfaces, without changing these gloves.
6. Your firm failed to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces [21 CFR 110.20(b)(6)]. Specifically, on May 22, 2012, during the manufacturing of (b)(4) brand pizza shells on both packaging lines (b)(4), our investigator observed that the cooling fans directly over the conveyer system and finished product are soiled and filled with debris.
7. Your firm’s plumbing constitutes a source of contamination to food and water supplies [21 CFR 110.37(b)(3)]. Specifically, on May 22, 2012, our investigator observed that the water supply line to the ice machine, located in the packing room, is soiled with an unknown black and brown colored substance. The ice from this machine is used as an ingredient in every batch of (product) manufactured.
At the conclusion of the inspection, Christopher L. Thompson, Vice President was presented with form FDA-483 (Inspectional Observations form) listing these deviations from the regulations. He informed our investigator that appropriate corrective action would be taken. A copy of the FDA-483 is enclosed with this letter.
Your significant labeling violations are as follows:
8. Your (b)(4) Sicilian Pizza Crust, (b)(4) Pizza Crust (b)(4), and (b)(4) Deli Style Pizza products are misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), that that the labels failure to declare all major food allergens present in those products, as required by section 403(w)(1) of the Act. Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as 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. 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 is 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, 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)].
Further guidance and information on food allergens can be accessed on FDA’s website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.
Your labels fail to declare the following major food allergens:
- Wheat: (b)(4) Sicilian Pizza Crust and (b)(4) Pizza Crust (b)(4) contain wheat.
- Wheat and milk: (b)(4) Deli Style Pizza contains wheat and milk.
9. Your (b)(4) Sicilian Pizza Crust, (b)(4) Deli Style Pizza, (b)(4) Pizza Crust (b)(4) products are misbranded under section 403(i)(2) of the Act, 21 U.S.C. 343(i)(2), because they are fabricated from two or more ingredients but the labels fail to bear the common or usual name of each ingredient. Specifically,
- Your (b)(4) Sicilian Pizza Crust and (b)(4) Deli Style Pizza products are made using the ingredient (b)(4) which contains bleached wheat flour, malted barley flour, niacin, iron (reduced), potassium bromate, thiamine mononitrate, riboflavin and folic acid. Your labels fail to declare many of these ingredients. In addition, your recipes for each of these products contain additional ingredients, some of which are multi-ingredient foods. In some cases all the ingredients identified in the recipe are not declared, as well as, some of the sub-ingredients (e.g., the sub-ingredients of the cheeses are not declared on the (b)(4) Deli Style Pizza label).
- Your (b)(4) Sicilian Pizza Crust, (b)(4) Deli Style Pizza, and (b)(4) Pizza Crust (b)(4) declare either shortening, vegetable shortening, or vegetable oil as ingredients. “Shortening”, “Vegetable Shortening”, and “Vegetable Oil” are not appropriate common or usual names under 21 CFR 101.4(b)(14), which requires that each individual fat and/or oil ingredient of a food intended for human consumption shall be declared by its specific common or usual name (e.g., “beef fat,” “cottonseed oil”).
According to 21 CFR 101.4(b)(2), the requirement to list component ingredients (or “sub-ingredients”) may be met by either (i) parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or (ii) 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.
10. Your (b)(4) Sicilian Pizza Crust, (b)(4) Pizza Crust (b)(4), and (b)(4) Deli Style Pizza products are misbranded within the meaning of section 403(q) of the Act, 21 U.S.C. § 343(q), in that the nutrition information on the label does not comply with the requirements in 21 CFR 101.9. Specifically,
- Your labels for (b)(4) Sicilian Pizza Crust and (b)(4) Pizza Crust (b)(4) products do not contain a statement of the number of grams of trans fat in a serving or if a statement of the trans fat is not required, your product labels do not contain the statement “Not a significant source of trans fat” at the bottom of the table of nutrient values [21 CFR 101.9(c)(2)(ii)].
- Your label for (b)(4) Deli Style Pizza fails to base the nutrition information on an appropriate serving size. The Reference Amount Customarily Consumed (RACC) for pizza is 140 g (see 21 CFR 101.12(b) (Mixed Dishes not measurable with a cup)). The serving size for a pre-sliced pizza containing 8 (60 g slices) is 2 slices (120 g). The declared nutrition information for this product is based on 1 slice which is half the actual serving size.
You should take prompt action to correct the violations described above. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.
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.
During our label review we also noted these additional observations:
- Your Pizza Crust (b)(4) Pizza Shells product is manufactured using the same recipe as the Mini Pak product and its labeled vitamin and mineral declaration is as follows: vitamin A is 0 %, calcium is 0%, vitamin C is 0%, and Iron is 4%. The declaration of vitamins and minerals is required to be an accurate representation of the product in accordance with 21 CFR Part 101.9. We recommend that you verify all of the information contained on your product labels.
- The label for the (b)(4) Deli Style Pizza product declares “4 Cheese Blend,” but the ingredient statement only lists two cheeses.
- The label for your (b)(4) Deli Style Pizza product fails to declare the ingredient statement and name/place of business information on the same panel (21 CFR 101.2(d)).
- We note that the ingredient statements are provided within the Nutrition Facts labels for these products. This information is not provided under 21 CFR 101.9.
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.
This letter may not list all the violations in your product labeling or at your facility. You are responsible for ensuring that your firm operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. You are also responsible for ensuring that all of your products and their labeling are in compliance with the laws and regulations enforced by FDA. In addition to consulting the Act and Title 21 of the CFR, further guidance and information on food allergens can be accessed on FDA’s website at: http://www.fda.gov/Food /GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm and http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.
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 Lynn.Bonner@fda.hhs.gov.