Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
RETURN RECEIPT REQUESTED
April 23, 2014
Mr. Young Nam Cho, Co-owner and President
Cho & So, Incorporated
DBA Oh Bok Bakery
248 West Wingohocking Street
Philadelphia, PA 19140-1543
Dear Mr. Cho:
The Food and Drug Administration (FDA) conducted an inspection of your bakery located at 248 West Wingohocking Street, Philadelphia, PA, on October 24 – 25, 2013; October 28, 2013; November 8, 2013 and November 12, 2013. During the inspection, the FDA investigators documented serious violations of the Current Good Manufacturing Practice regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). The inspection revealed that food processed at your facility is 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 the food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth. In addition, our review of the labeling for your products including other evidence collected by our investigators indicates that your firm’s products including Korean Cake and Roll Cake products are misbranded under Section 403 of the Act [21 U.S.C. § 343]. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
The following significant violations were observed during the inspection:
1. The firm failed to take effective measures to exclude pests and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, on October 24, 2013, our investigators observed the following:
A. Thirty-three (33) rodent excreta pellets on a pallet containing 50 pound bags of flour and sugar.
B. Two uncovered containers of rodent poison in the food packaging area, and one uncovered container of rodent poison in the break area.
C. Sticky fly tapes hanging above exposed food.
D. Mouse traps were not properly positioned against the walls.
E. One and half inch opening on one side of the overhead door in the warehouse, and up to a 1.5 inch opening under the overhead door.
2. The firm failed to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests within the immediate vicinity of the plant buildings or structures, as required by 21 CFR 110.20(a)(1). Specifically, the rear exterior of the building is overgrown with weeds, pallets, old equipment, and other debris.
3. The firm failed to clean food-contact surfaces as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d). Specifically, our investigators observed old food residue on the food contact surfaces on the steam mixer and the rollers.
4. The firm failed to use equipment and utensils that allowed for proper cleaning, as required by 21 CFR 110.40(a). Specifically, the firm was using non-food grade lubricating oils on gear assemblies for food rolling machines.
5. The firm failed to apply procedures that provide adequate cleaning and sanitizing of equipment, as required by 21 CFR 110.35(d)(5). For example, on October 28, 2013, our investigator observed the firm using only (b)(4) on the food contact surfaces.
6. The firm failed to sanitize and thoroughly dry, prior to use, food contact surfaces which have been wet cleaned, as required by 21 CFR 110.35(d)(1). Specifically, On October 25, 2013, our investigator observed plastic strainers, buckets and lids used to hold food, stacked before drying.
7. The firm failed to smoothly bond or well maintain seams on food contact surfaces, to minimize accumulation of food particles and dirt and the opportunity for growth of microorganisms, as required by 21 CFR 110.40(b). For example, the (b)(4) mixing bowl used to mix the ingredients for all the firm’s products, had rough welds on the food contact surface.
8. The firm’s plumbing constitutes a source of contamination to food, as required by 21 CFR 110.37(b)(3). Specifically, our investigators observed a dead leg, beneath the hand washing sink in the packaging room that measure ½ “ by 15 ½”.
9. The firm’s plumbing lack backflow protection from piping systems that discharge, as required by 21 CFR 110.37(b)(5). For example, there was no backflow protection for a hose in the production room, two hoses in the packaging room near the garage door, and the hose in the exterior of the rear of the building.
10. The firm failed to provide safety type lighting fixtures suspended over exposed food, as required by 21 CFR 110.20(b)(5). Specifically, on October 24, 2013, our investigator observed the overhead light fixtures were not shielded above exposed food, and in some cases the lights were missing end caps above exposed food.
11. The firm failed to clean non-food contact surfaces of equipment as frequently as necessary to protect against contamination, as required by 21 CFR 110.35(d)(3). For example, the firm’s three hand washing sinks were soiled.
1. Your Korean Cake product is misbranded under Section 403(w) of the Act, [21 U.S.C. § 343(w)], in that the finished product label fails to declare the known major food allergen, wheat, as specified by 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:
i. 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
ii. 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)].
Specifically, your Korean Cake product lists the ingredients: flour, sugar, egg, yellow spirit bean, corn syrup, milk powder, salt, baking powder, and baking soda. However, the flour contains the ingredient, “wheat” a known allergen that is not declared on the product label.
2. Your Korean Cake and Roll Cake products are misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each product is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4.
i. Your Korean Cake and Roll Cake products are manufactured using the ingredient (b)(4) Flour Bleached,” which contains bleached wheat flour, malted barley flour, niacin, iron, potassium bromate, thiamin mononitrate, riboflavin, and folic acid; however, you fail to list these sub-ingredients on your finished product label.
ii. Your Korean Cake product is manufactured using the ingredient “Baking Powder,” which is a multicomponent ingredient; however, you fail to list the sub-ingredients on your finished product label.
iii. The cream filling in your Roll Cake product is manufactured using the ingredient (b)(4),” which contains partially hydrogenated soybean oil and partially hydrogenated cottonseed oil; however, you fail to list these sub-ingredients on your finished product label.
iv. Your Korean Cake product declares “Vegetable Oil;” however, that is not the common or usual name of the oil ingredient; Specifically, 21 CFR 101.4(b)(14), requires that each individual fat and or oil ingredient of a food intended for human consumption must 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)." Your Korean Cakes product declares “vegetable oil” as an ingredient but fails to list the specific components of the oil ingredient. The term vegetable oil," on its own, is not a proper common or usual name because it does not list the common or usual name of each component fat or oil, as required by 21 CFR 101.4(b)(14).
According to 21 CFR 101.4(b)(2), 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.
3. Your Roll Cake product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)], in that it lacks a nutrition label in accordance with 21 CFR 101.9.
i. The serving size declaration is not expressed in common household measure, in accordance with 101.9(b)(5) and 21 CFR 101.12(b). A sample label statement is “(__pieces)” for distinct pieces, (e.g. cupcake) or fractional slice (__g) for large discrete pieces.
ii. The declared serving size weight (113g) and number of servings per container (about 4) are not consistent with the declared net quantity of contents (10 oz (283g)). Based on the information provided on the label, a consumer would expect the product to contain almost 16 oz of Roll Cake.
4. Your Korean Cake and Roll Cake products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)], because your product labels contain information in two languages but do not repeat all the required label information in those different languages. In accordance with 21 CFR 101.15(c)(2) and (3), 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.
We also note the following labeling comments:
1. Your Korean Cake product declares “yellow spirit bean” as an ingredient. It is unclear if that is the common or usual name of the ingredient; however, if this is a type of soybean, it must be captured as a major food allergen, in accordance with 403(w).
2. Your Roll Cake product declares a serving size of 113g; however, the Reference Amount Customarily Consumed (RACC) does not appear to be correct. In accordance with 21 CFR 101.12(b), the RACC of light weight, medium weight and heavy weight cakes are 55g, 80g, and 125g, respectively.
This letter may not list all the violations at your facility. You are responsible for ensuring that your food facility operates in compliance with the Act and the Current Good Manufacturing Practice regulations (21 CFR Part 110) and food labeling regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Failure to implement lasting corrective actions of these violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
We request that you notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation such as certification of actions performed by a licensed exterminator; other actions performed to control unauthorized entrance of pests; your strategy to protect food products from possible contamination; copies of revised labels, and/or or any other useful information that would assist us is evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.
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.
Your written response should be sent to Robin M. Rivers, Compliance Officer, United States Food and Drug Administration, U.S. Customhouse, Room 900, 2nd & Chestnut Streets, Philadelphia, PA 19106. If you have any questions regarding any issues in this letter, please contact Ms. Rivers at 215-717-3076 or e-mail at Robin.Rivers@FDA.HHS.GOV.
Kirk D. Sooter
cc: Mrs. Meeae Cho, Co-owner
Cho & So, Incorporated
DBA Oh Bok Bakery
248 West Wingohocking Street
Philadelphia, PA 19140-1543
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Director
City of Philadelphia
Philadelphia Department of Public Health
321 University Avenue, Second Floor
Philadelphia, PA 19104
Attention: Dr. Palak Raval-Nelson, Phd, Director
Mr. Bernard Finkel, Chief, Food Protection