East Asia Noodle Co Inc 8/13/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||PHILADELPHIA DISTRICT|
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
RETURN RECEIPT REQUESTED
August 13, 2012
Glenn J. Mark, President
East Asia Noodle Co., Inc.
212 N. 11th Street
Philadelphia, PA 19107-1729
Dear Mr. Mark:
The U.S. Food and Drug Administration (FDA) inspected your processing facility, located at 212 N. 11th Street, Philadelphia, PA on May 24, 2012 through May 31, 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 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 employees failed to use suitable outer garments to protect against the contamination of food and food contact surfaces [21 CFR 110.10(b)(1)]. Specifically, on May 24, 2012, during the production of Wonton Skins and Egg Roll Skins, our investigator observed:
- An employee reaching into a vat to remove a thickened mixture, which was to be used for the production of wonton skins. This employee was not wearing sleeve protection, and the inside of his arm was in contact with the food mixture.
- An employee was leaning forward while feeding egg roll skins into the rolling machine. His un-tucked, half buttoned shirt was touching the solid sheet of egg roll skin product.
2. 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, you informed our investigator that your firm’s food production employees have not received any formal training in food handling techniques, and food protection principles. We acknowledge that you also informed our investigator that your employees have a language barrier, in that they do not understand English. However, this does not alleviate you of the responsibility of training them in proper food handling techniques and food-protection principles.
3. Your firm failed to provide hand washing facilities at each location in the plant, where needed, to protect against contamination [21 CFR 110.0(e)(1)]. Specifically, on May 24, 2012, during the production of Egg Roll Skins, our investigator observed that there was no sink in the upstairs bathroom, above the production area. We acknowledge that prior to the close of the inspection a sink was installed with warm running water, a soap dispenser, and towels. However, the fact that your firm failed to have adequate hand washing facilities is of immense concern to FDA and we must stress the importance of this aspect of food safety.
4. Your firm failed to provide effective hand preparations for employee’s [21 CFR 110.37(e)(2)]. Specifically, on May 24, 2012, our investigator observed that there was no soap at the hand washing station in the production area, and there was no soap in the first floor bathroom. We acknowledge that prior to the close of the inspection, soap dispensers were installed at both the hand washing station in the production area, and in the first floor bathroom. However, the fact that your firm failed to have adequate hand preparations for hand washing is of immense concern to FDA and we must stress the importance of this aspect of food safety.
Your significant labeling violations are as follows:
5. Your Egg Roll Skins, Fried Noodles, Egg Noodles, and Wonton Skin products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the product labels fail to identify the major food allergen, wheat, as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines “major food allergens” as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans; as well as any food ingredient containing 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 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 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 (e.g., “Whey (Milk)”), except 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)].
6. Your Egg Roll Skins and Wonton Skin 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, these products are manufactured using the ingredient (b)(4) which contains durum wheat, niacin, thiamine, riboflavin, and folic acid; however you fail to list these sub-ingredients on your finished product labels.
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, or by listing the component ingredients 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.
7. Your Fried Noodles product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], in that the labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count. Specifically, the product label for your Fried Noodles fails to bear a net weight declaration.
8. Your Egg Noodles product is misbranded within the meaning of section 403(g) of the Act [21 U.S.C. § 343(g)] because it is a food for which a definition and a standard of identity have been prescribed by regulation as provided under 21 CFR 139.150 but the product does not comply with the standard of identity. Specifically, your Egg Noodles product contains Yellow 5 and Yellow 6, which are allowed under the standard as ingredients for this food.
9. Your Egg Roll Skins, Fried Noodles, Egg Noodles, and Wonton Skin products are misbranded within the meaning of section 403(f) because your labels contain information in two languages but does not repeat all the required label information in both languages. 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.
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:
- Regarding your Egg Roll Skins, Egg Noodles, and Wonton Skin product labels, the net quantity of contents should be declared in terms of weight designated in metric terms in addition to U.S. Customary terms (P.L. 102-329, August 3, 1992; 21 CFR 101.105).
- We note that while your Egg Roll Skins and Wonton Skins products are sold primarily for further use or distribution, that there are occasions when they are sold directly to the consumer. When these products are sold directly to the consumer, the products must bear the nutrition information required by 21 CFR 101.9, unless an exemption applies.
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.
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