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CERTIFIED MAIL RETURN RECEIPT REQUESTED WARNING LETTER FLA0629 ...

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Cream Ice Cream Pie are the. immediate containers. of these. products and. therefore the unit carton is the product label where the ingredient ...

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CERTIFIED MAIL RETURN RECEIPT REQUESTED WARNING LETTER FLA0629 July 10 2006 Jeffery B. Pasch President Page 1DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 555 Winderley PI. Ste. 200 Maitland Fl 32751 CERTIFIED MAIL RETURN RECEIPT REQUESTED WARNING LETTER FLA0629 July 10 2006 Jeffery B. Pasch President Jeffs Gourmet Pies Inc. 6704 Parke East Boulevard Tampa Florida 336104145 Dear Mr. Pasch: On March 2 2006 the Food and Drug Administration (FDA) conducted an inspection of your plant located at the above address. During the inspection we collected labeling for some of your products. Our review of this labeling found serious violations of the Federal Food Drug and Cosmetic Act (the Act) and FDA's implementing regulations in Title 21 Code of Federal Regulations (21 CFR) Part 101 Food Labeling. You can find the Act and FDA regulations through links in FDA's homepage at www.fda.gov. Ingredient labeling Your Plain Cheesecake Triple Chocolate Supreme Layer Cake and Cookies & Cream Ice Cream Pie 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 their labels fail to declare the common or usual name of each ingredient as required by 21 CFR 101 .4. The label of a product is defined in section 201(k) of the Act 21 US.C. 321(k)] as "a display of written printed or graphic matter upon the immediate container of any article . . . ... The unit cartons of your Plain Cheesecake Triple Chocolate Supreme Layer Cake and Cookies & Cream Ice Cream Pie are the immediate containers of these products and therefore the unit carton is the product label where the ingredient statement must appear along with the other information displayed there. None of these three products bears an ingredient statement on the unit carton. Page 2We remind you that under 21 CFR 101 .4(b)(2) all component ingredients of ...

Source: www.fda.gov

 

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