Inspections, Compliance, Enforcement, and Criminal Investigations

Chris A Papas and Son Co 10/20/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775 

 

WARNING LETTER
CIN-16-456719-01
 
 
Via UPS
 
October 20, 2015
 
Carl A. Papas, President
Chris A. Papas, Vice-President
Chris A. Papas and Sons Co.
921 Baker Street
Covington, KY 41011
 
Dear Messers Papas:
 
The Food and Drug Administration (FDA) conducted an inspection on January 21-30, 2015, of your food manufacturing facility located at 921 Baker Street, Covington, KY. The inspection found significant violations of the FDA’s Current Good Manufacturing Practice (CGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations Part 110 (21 CFR Part 110). These violations cause the foods manufactured at 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. 
 
Furthermore, our investigator collected labels of your products. Based on our review, we have determined that your candy products are misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343] and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 [21 CFR Part 101]. You may find the Act and FDA regulations through links at FDA’s home page at http://www.fda.gov.
 
Your significant violations include:
 
Adulteration Violations
  1. You failed to perform filling, assembling, and packaging in a manner that protects food from becoming contaminated per 21 CFR Part 110.80(b)(13). Specifically,
    1. Our investigator observed the manufacturing of a product containing coconut (coconut cream candy eggs) followed by a non-nut containing product (dark chocolate opera cream candy eggs) on the same production line without thoroughly cleaning the manufacturing equipment.
    1. Your production records also demonstrated you immediately manufactured a product containing tree nuts (maple nut cream candy eggs) followed by a non-nut containing product (French cream candy eggs) without thoroughly cleaning the manufacturing equipment.
    1. Chocolate is continuously circulated in the system to manufacture products that contain major food allergens, including peanuts, pecans and coconuts, and products that do not contain allergens without properly cleaning the manufacturing equipment.
  1. You must ensure that employees hands are washed thoroughly in an adequate hand washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, as required by 21 CFR Part 110.10(b)(3). Specifically, your employees were observed not washing their hands after touching non-food contact surfaces including their faces, clothing, and non-food contact equipment while using their bare hands to manufacture cherry cream candy eggs. Further, the company President was not observed washing his hands before touching in-process candy and food contact manufacturing equipment.
  1. Your procedure used for cleaning and sanitizing of equipment has not been shown to provide adequate cleaning and sanitizing treatment as required by 21 CFR Part 110.35(d)(5). Specifically, your firm only utilizes hot water and bleach to clean and sanitize manufacturing equipment. However, a detergent or surfactant is necessary to properly wash, rinse, and sanitize your food contact surfaces. 
Misbranding Violations
  1. Your Papa’s Chocolate Covered Easter Eggs are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare completely and accurately all major food allergens present in the products, such as wheat, milk, and egg, 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 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:
  • 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)].
For example:
  • Your 6-count Multipack Chocolate Covered Cream Easter Egg, Vanilla Cream Dark Chocolate Easter Egg, and Cherry Cream Dark Chocolate Covered Easter Egg products are manufactured using soy lecithin, however, your labels fail to declare the major allergen soy.
  • Your Maple Nut Cream Dark Chocolate Covered Easter Egg product is manufactured using soy lecithin and pecans; however, your label does not declare the major allergens soy and pecans. The ingredient list declares “nuts” which is not adequate, the specific type of nut must be declared.
Further guidance and information on food allergens can be accessed on FDA’s website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm. 
  1. Your Papa’s Chocolate Covered Easter Eggs 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, but the labels fail to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4. For example,
  • Your Vanilla Cream Dark Chocolate Covered Easter Egg product is manufactured using dark chocolate-flavored coating and vanilla flavoring, however the label for the finished product fails to declare the sub-ingredients contained in dark chocolate-flavored coating including chocolate liquor, cocoa butter and vanilla. In addition, the label fails to declare the sub ingredients contained in the vanilla flavoring, including the colors FD&C Yellow #5, FD&C Red #40, and FD&C Blue #1.
  • Your Cherry Cream Dark Chocolate Covered Easter Egg product is manufactured using dark chocolate-flavored coating and cherries, however the label for the finished product fails to declare the sub-ingredients contained in dark chocolate-flavored coating including chocolate liquor, cocoa butter and vanilla. In addition, the label declares fruit as an ingredient rather than cherries.
  • Your Maple Cream Dark Chocolate Covered Easter Egg product is manufactured using dark chocolate-flavored coating and pecans, however the label for the finished product fails to declare the sub-ingredients contained in dark chocolate-flavored coating including chocolate liquor, cocoa butter and vanilla. In addition, the label declares nuts as an ingredient rather than pecans.
  • Your 6-count Multipack Chocolate Covered Cream Easter Egg product fails to declare all of the ingredients that are in all chocolate covered cream eggs for which this label is used. The label is not consistent with the exemptions from labeling in 21 CFR 101.100(a)(1), which permits such labeling when “in terms which are as informative as practical and which are not misleading.” In cases where such labeling is necessary, those ingredients common to all items should be listed first in the ingredient declaration followed by a listing of ingredients not common to all, including specific indications of which ingredients are actually present in designated articles. Few instances will defy such organization and with the possible exception of candy assortments, the statement of identity in conjunction with the ingredient declaration must enable the consumer to tell exactly what is in each article of food. The common ingredients in your product are not listed first and it is not evident how one type of chocolate egg is distinguished from one another. Further, the ingredients that are not common to all of the products using this packaging must be distinguishable for the specific products where it is used. Additionally, nuts and fruits are not appropriate common or usual names per 21 CFR 101.4, the grouping of the carbohydrase enzymes is not permitted, and the color is not declared in accordance with 21 CFR 101.22(k). 
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 multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food. 
  1. Your Papa’s Chocolate Covered Easter Eggs products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g., Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. For example:
  • Your Vanilla Cream, Cherry Cream and Maple Nut Cream Dark Chocolate Covered Easter Egg products fail to bear nutrition information in accordance with 21 CFR 101.9(a).
Your firm may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review the nutrition labeling exemptions in 21 CFR 101.9(j)(18) [or see http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm053857.htm] for information on filing for an annual exemption. The application may be submitted online at: https://www.accessdata.fda.gov/scripts/NLE/client/login.cfm. We have no record of your firm having filed a Small Business Nutrition Labeling Exemption Notice.
  1. Your Papa’s Vanilla Cream, Cherry Cream and Maple Nut Cream Dark Chocolate Covered Easter Egg products are misbranded within the meaning of 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the labels fail to declare “cream” in the ingredients statements.
We also note the following comments: 
  • We question how the nutrition facts panel on the 6-count Multipack Chocolate Covered Cream Easter Egg product can represent the nutritional content of every variety of chocolate covered cream egg within the pack.
  • We are unclear of the intent of the advisory labeling on the 6-count Multipack Chocolate Covered Cream Easter Egg product, which states “Allergy Information: Shares equipment with products containing peanuts, tree nuts, products containing milk, eggs and wheat. Milk may be present” especially when milk is present in the product as an added ingredient.
Section 740 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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31 (a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-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. 
 
Please send your reply to the Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237, Attention: Allison Hunter. If you have any questions about this letter, please contact Compliance Officer Hunter at (513) 679-2700 ext. 2134 or by email at allison.hunter@fda.hhs.gov.
 
 
Sincerely yours,
/S/
Steven B. Barber
District Director
Cincinnati District

 

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