Lucky Fortune Cookies, Inc. 8/30/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707
August 30, 2013
Return Receipt Requested
Ms. Jessica S. Yeung, Manager
Lucky Fortune Cookies, Inc.
8060 Washington Blvd.
Jessup, MD 20794-9449
Dear Ms. Yeung:
We inspected your firm, a manufacturer of ready-to-eat (RTE) fortune cookies, located at 8060 Washington Blvd., Jessup, MD on February 26 and 28, 2013. The inspection found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulation in manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 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 contaminated with filth or rendered injurious to health. Furthermore, FDA conducted a review of labels for your fortune cookie product and found significant violations of the labeling regulations for foods, 21 CFR 101. These violations cause your fortune cookies, to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov
Specifically, our inspection of your facility revealed the following cGMP violations:
1.) Your firm failed to maintain physical facilities in repair sufficient to prevent food from becoming adulterated as required by 21 CFR 110.35(a). Specifically, our Investigators observed that ceiling panels located directly above the manufacturing area where finished cookies are exposed were peeling and there were missing ceiling panels above the heater located over large oven # 2.
2.) Your firm failed to take effective measures to protect against the inclusion of metal and extraneous material in food as required by 21 CFR 110.80(b)(8). Specifically, our Investigator observed on February 26, 2013 that a piece of metal was intentionally passed through as a test and went undetected by your metal detector.
1. Your Fortune Cookie (5.5 LBS. and individually wrapped) products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the label fails to declare the major food allergen “wheat” as required by 403(w) of the Act. Specifically, the product is manufactured using wheat flour; however, you fail to declare the presence of wheat on the finished product labels.
Section 201 (qq) of the Act [21 U.S.C. § 321 (qq)] defines as "major food allergens" milk, egg fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredients containing proteins derived from one of these foods, with the exception of highly refined oils or ingredients derived from such 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 (e.g,. “wheat flour”), or the name of the food source that 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 Fortune Cookie (5.5 LBS.) product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)], in that the label fails to bear nutrition information, as required by 21 CFR 101.9. For example:
- The reference amount customarily consumed (RACC) for cookies is 30 g (see 21 CFR 101.12); therefore, the serving size for this product should be four (4) cookies (32g), not one (1) cookie as your label declares. The serving per container and the nutrient information are incorrect because they are not based on the proper serving size.
- The Calories from Fat content is not declared as required by 21 CFR 101.9(c)(1)(ii).
- Your label does not list Trans Fat content as required by 21 CFR 101.9(c)(2)(ii).
- Your label does not list vitamins and minerals as required by 21 CFR 101.9(c)(8)(ii).
- Percent Daily Values are not declared as required by 21 CFR 101.9(c).
3. Your Fortune Cookie (individually wrapped) is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)] in that product’s plastic wrapper fail to bear the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.5.
4. Your Fortune Cookie (5.5 LBS) product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that it is fabricated from two or more ingredients and the labels fails to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Your product label declares “hydrogenated vegetable shortening” as an ingredient; however, your product was observed being manufactured with (b)(4), which was not declared on the label. Vegetable shortening is not the common or usual name for (b)(4).
You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective action may result in FDA taking regulatory action such a seizure or injunction without further notice.
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 cost. 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 mean 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.
Additional labeling comments:
- (b)(4) is an ingredient used to manufacture your fortune cookie product. If the (b)(4) that is used is a multi-component ingredient, those sub-ingredients should be declared on the product label. The requirement to list these component ingredient (or “sub-ingredients”) may be met by either parenthetically listing the component ingredient after the common or usual name of the main ingredient, or by listing the component ingredient without listing the 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.
- Your product label includes nutrients that are not declared correctly. For example:
o Total Fat content is not expressed in accordance with 21 CFR 101.9(c)(2). When a serving contains less than 0.5 g of total fat, it should be expressed as zero;
o Saturated fat is not declared in accordance with 21 CFR 101.9(c)(2)(i). When serving contains less than 0.5 mg of saturated fat, it should be expressed as zero:
o Cholesterol content is not expressed in accordance with 21 CFR 101.9(c)(3). When a serving contains less than 2mg of cholesterol, it should be expressed as zero;
o Sodium content is not expressed in the increments required under 21 CFR 101.9(c)(4). For Sodium levels between 5 and 140 mg the sodium must be declared in 5 mg increments.
o Potassium content is not expressed in accordance with 21 CFR 101.9(c)(5). When a serving contains less than 5 mg of potassium, it should be expressed as zero.
o Total Carbohydrate content is not expressed to the nearest gram [21 CFR 101.9(c)(6)].
o Dietary Fiber content is not expressed in accordance with 21 CFR 101.9(c)(6)(i). When a serving contains less than 0.5 g of dietary fiber it should be expressed as zero.
o Sugar content is not declared is not expressed in accordance with 21 CFR 101.9(c)(6)(ii). When a serving contains less than 0.5 g of sugar it should be expressed as zero.
o Protein content is not expressed to the nearest gram [21 CFR 101.9(c)(7)].
o The name of the distributor is not permitted to be included within the nutrition label.
- The bulk container and individual wrappers contain characters in a foreign language. Title 21 CFR 101.15(c)(2) requires that if the label contains any representation in a foreign language, all words, statements and other information required by or under authority to the Act to appear on the label must appear thereon in the foreign language.
- During the inspection, you stated that (b)(4) is used during certain months of the year in place of (b)(4), and that (b)(4) is not always used to manufacture the product. If you manufacture your product using different ingredients at different times, you must provide different labels to accurately reflect the ingredient used in the product.
This letter may not list all the violations at your facility. You are responsible for ensuring you operate in compliance with the Act and all applicable regulations, including the Current Good Manufacturing Practice regulation (21 CFR 110) and food labeling regulation (21 CR 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations noted above. You should include in your response, documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and stat when you will correct any remaining violation.
Please send your reply to the U.S. Food and Drug Administration, Attention: Ernest F. Bizjak, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Bizjak by phone at 410-779-5715 or by email at firstname.lastname@example.org.
Baltimore District Office