Inspections, Compliance, Enforcement, and Criminal Investigations
Global Bakery Corporation 10/31/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|466 Fernandez Juncos Avenue|
San Juan, Puerto Rico, 00901
OCT 31, 2011
VIA OVERNIGHT MAIL
Return Receipt Requested
Mr. Antonio Stakun
Manager and Owner
Global Bakery Corporation
P. 0. Box 244
Fajardo, Puerto Rico 00740
Dear Mr. Stakun:
The United States Food and Drug Administration (FDA) conducted an inspection of your bread and pastry products manufacturing facility located at Road 195 km 1.5 Norte Industrial Park, Puerto Real, Fajardo, Puerto Rico 00738 on June 1 -2, 8 and 14, 2011. During the inspection, samples and copies of your labeling were collected. Our review of your labeling found that your firm's products are not labeled in accordance with Title 21 CFR Part 101, Food Labeling regulation, (21 CFR Part 101 ). These violations cause your Mini Turnover Pifia, Guayaba Turnover, and Italian Cookies Rainbow, products to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (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 Mini Turnover Pifia, Guayaba Turnover, and Italian Cookies Rainbow products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the labels fail to provide nutrition information in accordance with 21 CFR 101.9. Specifically,
• These product labels make a claim about fatty acids ("0 Trans Fat") but fail to declare the number of grams per serving of polyunsaturated fat and monounsaturated fat in the nutrition label as required by 21 CFR 101.9(c)(2)(iii) and (iv).
• The serving size for your Mini Turnover Pina is not declared in accordance with 21 CFR 101.9(b)(2)(i)(A). For products in discrete units (e.g., muffins), if a unit weights 50 percent or less of the reference amount, the serving size shall be the number of whole units that most closely approximates the reference amount for the product category. The Reference Amount Customarily Consumed (RACC) for turnovers is 125 g (21 CFR 101.12(b), Table 2). Based on your label, one mini turnover phia is 33.5 g. Therefore, the serving size should be declared as 4 units. Your labels incorrectly list the serving size as "1 (1.20oz)(33.5g)." The nutrition values and servings per container information provided in the labeling of your product must be based on the correct serving size.
• The serving size for your Italian Cookies Rainbow product is declared as "8-10." As required by 21 CFR 101.9(b)(8)(ii), the number of servings must be rounded to the nearest whole number and rounding should be indicated by the use of the term "about."
2. Your Mini Turnover Piiia, Guayaba Turnover, and Italian Cookies Rainbow 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 each ingredient is not declared on the label, as required by 21 CFR 101.4. Specifically,
• Your Mini Turnover Pina is made with pineapple filling that contains agar and artificial color; however you failed to declare these sub-ingredients.
• Your Guayaba Turnover is made with guava filling that contains sodium benzoate; however you failed to declare this sub-ingredient.
• Your Italian Cookies Rainbow is made with enriched wheat flour and rainbow candy bits (both are multi-component ingredients); however, you failed to declare their sub-ingredients.
The requirement to list these component ingredients (or "sub-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. Under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
• Your Mini Turnover Piiia and Guayaba Turnover product labels declare "potassium" as a sub-ingredient of the "enriched wheat flour"; however, potassium is not a permissible sub-ingredient under the requirements for the standardized food enriched flour [see 21 CFR 137 .165].
• Your Mini Turnover Pina and Guayaba Turnover product labels declare "vegetable oil" as a sub-ingredient of "vegetable lard." In addition, your Italian Cookies Rainbow product label declares "vegetable shortening" as an ingredient. Both "vegetable oil" and "vegetable shortening" 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") 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)."
Furthermore, we have the following comments:
• If any of your bakery products contain any of the major food allergens defined in section 201 (qq) of the Act [21 U.S.C. § 321 (qq)] (i.e. milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans), you must declare those major food allergens in accordance with section 403(w) of the Act [21 U.S.C. § 343(w)]. 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 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. 11 flour (wheatt), 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).
• Your Mini Turnover Pina, Guayaba Turnover, and Italian Cookies Rainbow product labels do not use the term "net weight" when stating the net quantity of contents on the principal display panel, in accordance with 21 CFR 101.1050)(3).
• Your Mini Turnover Pina, Guayaba Turnover, and Italian Cookies Rainbow product labels fail to declare the serving size in terms of common household units. A description of the individual unit shall be used for products in discrete units (e.g., piece, slice, cracker, bar) as required by 21 CFR 101.9(b)(5)(iv). Your labels declare "1" but provide no units.
• The name of the nutrient is "Dietary fiber" in accordance with 21 CFR 101.9(c)(6)(i). However, your Mini Turnover Piria, Guayaba Turnover, and Italian Cookies Rainbow product labels declare the nutrient as "Fiber."
• In accordance with 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Because your product is distributed solely in Puerto Rico, it is acceptable for it to be labeled solely in Spanish; however, if it contains any information in another language, such as English, all of the required label information must appear in both languages. Your Mini Turnover Piria product label does not contain a statement of identity and net quantity of contents statement in Spanish and is missing the footnote at the bottom of the nutrition facts panel in English. Your Guayaba Turnover product label fails to provide statement of identity, ingredients declaration and net quantity of contents statement in Spanish and the nutrition facts panel footnote is not provided in English. Your Italian Cookies Rainbow product label fails to provide a statement of identity and net quantity of contents statement in Spanish and the nutrition facts panel footnote is not provided in English.
We acknowledge that you provided our investigator with several revised labels on June 8, 2011 . The only revisions made to the labels were the addition of previously undeclared color additives. Therefore, the referenced labels remain misbranded as described above. You also indicated that you had begun to use the revised labels on June 8, 2011. We note that for your Mini Turnover Piria, Guayaba Turnover, and Italian Cookies Rainbow products, the revised labels improperly declare FD&C Yellow No. 5 and FD&C Red No. 40 with the prefix "SD&C" rather than "FD&C."
This letter is not meant to be an all-inclusive list of the violations at your establishment. You are reminded that it is your responsibility for ensuring that your firm operates in compliance with the Act and all 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. Such action includes seizure and/or injunction.
Please 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 may include in your response copies of the revised labels for the products that your firm manufactures and distributes, or other useful information that would assist us in evaluating your corrections. If you can not complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.
Your written reply to these concerns should be directed to the Food and Drug Administration, attention: Carlos A. Medina, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Medina at (787) 474-9538.
San Juan District
Enclosed: FDA 483