Inspections, Compliance, Enforcement, and Criminal Investigations
An Xuyen Bakery, Inc. 2/20/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26tb Ave SE, Suite 210
Bothell, WA 98021
February 20, 2013
In reply refer to Warning Letter SEA 13-12
Quang Q. Huynh, Owner
An Xuyen Bakery, Inc.
dba An Xuyen French Baking, LLC
19043 International Blvd.
Seatac, Washington 98188
Dear Mr. Huynh:
The Food and Drug Administration (FDA) conducted an inspection of your bakery located at 19043 International Blvd., Seatac, Washington, on September 11, 12, 13, 14, and 17, 2012. During the inspection, the FDA investigator 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 stored 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 bakery products and other evidence collected by our investigator indicates that your firm’s bakery products including French Bread, Nant Brioche, Strawberry Roll, Whole Wheat, Butter Rolls, Demi-Baguette, Hamburger Buns, Whole Wheat Croutons, and Garlic Croutons 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.
In addition, sample INV 754947, a filth exhibit, collected during the inspection, was analyzed by FDA’s Pacific Regional Laboratory Northwest. Laboratory analyses confirmed the presence of house ants from five different locations at your facility including inside two bins containing white sugar and an open bag of white sugar that are used in the production of your bakery products.
The following significant violations were observed during the inspection:
1. You failed to take effective measures to exclude pests from your facility and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c).
- At least ten dead small ants were observed in a bin containing white sugar in the southeast dry product storage area, at least three dead small ants were observed in an open 50 pound bag of white sugar stored on the floor in the southeast dry product storage area, and at least two live small ants were observed in an open plastic bin of white sugar stored directly beneath a shelving unit in the southeast dry product storage area.
- At least 20 live and dead ants were observed on shelving that holds bakery ingredients, crawling on the south wall, crawling on a five pound container of baking soda, one dead ant on a 50 pound bag of closed sugar, one live ant on a large plastic bin holding open white flour, one live ant on a closed 50 pound bag of cake donut mix, and one dead ant on a closed 50 pound bag of sugar. All were located in the southeast dry product storage area.
- At least ten small live, flies were observed adhering to the moist nylon bristles of basting brushes that are used to apply egg wash to pastry and oil to baking pans. The brushes were reported as having previously been cleaned.
- Two small flies were observed flying near the 3-compartment sink, one large fly observed flying in the dough preparation area, one small fly observed on a damp cloth towel in the southeast storage room, one large fly observed flying in the production mixing area during production of demi-baguettes, one small fly observed flying under the hand sink, one small fly observed flying above the 3-compartment sink, one small fly observed flying around the north end of the dish machine, three small flies observed flying around the mop sink, one small fly observed flying in the dough mixing area, and one small fly observed crawling on a black tote holding finished croutons.
2. You failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7).
- During three days of the inspection, the twelve foot wide delivery roll-up door in the product packaging area was observed open. Vertical hanging plastic curtain sheets left gaps between two and six inches from the floor.
- On each day of the inspection, the man door just north of the dishwasher was observed open approximately 3/8 of an inch.
- On each day of the inspection, the front exterior office door was observed wide open. A sliding door leading from the office to the production area was open throughout the inspection.
3. You failed to properly store equipment that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant building or structures, as required by 21 CFR 110.20(a)(1).
- On each day of the inspection, a large accumulation of bakery equipment, broken plastic racks, tubs, chemicals, soiled aprons, and other items used for food manufacturing were observed stored outside the front of the firm under two open awnings. Two birds were observed hopping on piled plastic bakery racks in this area. You stated that these racks were sometimes used in production.
- On each day of the inspection, an empty two-door refrigerator was observed unplugged and not operating by the southeast dry storage area with a pungent interior odor.
- A puddle of standing, turbid water was observed under the dishwasher and adjacent to the mop sink.
4. Employees did not wash hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3).
- Two employees were observed returning from break and entering the bakery production area without first washing their hands. The employees began working with dough using their bare hands.
- One employee was observed mixing dough with a large dough mixer and wiped his inside forearms and hands on each side of his face and then immediately returned to handling large portions of bread dough with his bare hands. He did not wash his hands or forearms after wiping his face before handling product.
5. You failed to store raw materials in a manner that protects against contamination, as required by 21 CFR 110.80(a)(1).
- An open 50 pound bag of flour was observed stored directly on the floor by the wooden baker table along the west wall of the bakery.
- An open 50 pound bag of white sugar was observed stored directly on the floor in the southeast product storage area.
- Frozen water drips and pools from an above condenser in the (b)(4) freezer were observed collecting on frozen packaged bakery ingredients and shelving directly beneath the condenser.
- A used flattened cardboard box was observed placed directly on top of open cups of measured yeast intended for production.
6. You failed to store finished food under conditions that would protect against physical and microbial contamination, as required by 21 CFR 110.93.
Specifically, a large uncovered black plastic bin containing finished croutons was observed with another bin of croutons stacked directly on top of it.
7. You failed to clean food contact surfaces as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d).
- On each day of the inspection, multiple metal dough racks were observed soiled with baked on foreign material. Processed, uncovered dough was placed into the racks on trays, with several trays stored approximately 3 inches below soiled portions of the racks.
- On each day of the inspection, a large dough machine was observed to be caked with an approximate ¼ inch buildup of foreign material on the dough chute and several other areas of the equipment.
8. The design and materials of your utensils do not allow proper cleaning, as required by 21 CFR 110.40(a).
- On each day of the inspection, dozens of raw wooden, approximately 3/8 inch thick boards were being used as direct food contact surfaces for dough produced by the bakery. The porous wooden boards were noted to have rough, cracked edges, splinters, and gouges.
- A soiled cloth portion of the dough conveyor belt was observed frayed and worn, creating holes in at least two areas.
- Green thin plastic sheets used for covering pastry dough were observed in the pastry room suspended from a refrigeration unit. The sheets were worn and contained holes.
9. You failed to construct and maintain equipment, containers and utensils used to convey, hold, and store food in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7).
- A large pastry bag used for piping filling into danish was observed heavily soiled with a black foreign material on both the interior and exterior of the bag.
- On each day of the inspection several tall, metal baking carts holding dough were observed to be soiled with crusted, chaffing, and baked food debris.
- Dripping liquid was observed from a tall, metal baking cart forming large drips directly above exposed resting dough in the rising walk-in refrigerator.
- Liquid was observed dripping onto the floor from two ceiling locations inside the 3-door walk-in proofer.
- Large plastic black and yellow bins used to hold finished croutons and crostini were observed to be cracked.
- Soiled metal baking racks were observed in use in the production area.
10. Your plumbing fails to provide a safe water supply, as required by 21 CFR 110.37(b)(3).
Specifically, the spray hose nozzle at the 3-compartment sink was observed lying directly in one of the sink basins. This created a potential back flow hazard in the water supply.
11. Your Strawberry Rolls and Nant Brioche products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the labels fail to declare all major food allergens present in the products, as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils, as “major food allergens.” 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:
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 adjacent to the list of ingredient, 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. “(milk)”), 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) [section 403(w)(1)(B) of the Act, 21 U.S.C. 343(w)(1)(B)].
Your food labels fail to declare the major food allergen, milk, which is a component of butter and/or cream.
12. Your Strawberry Roll, French Bread, Nant Brioche, and Whole Wheat products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that they fail to bear a “Nutrition Facts” panel as required by 21 CFR 101.9(a), and the products are not subject to an exemption. If you employ fewer than an average of 100 full-time equivalent employees, and have sold fewer than 100,000 units of each product within the last 12 months, you may be eligible to claim an exemption from nutrition labeling under 21 CFR 101.9(j)(18). You may refer to the following website for guidance on whether you would qualify and how to file for this exemption: http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/SmallBusinessNutritionLabelingExemption/default.htm.
13. Your French Bread, Nant Brioche, Strawberry Roll, Butter Rolls, Demi-Baguette, Hamburger Buns, Whole Wheat Croutons, and Garlic Croutons are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the labels do not include all of the sub ingredients of the enriched wheat flour used in these products, in accordance with 21 CFR 101.4(b)(2).
14. Your Strawberry Roll, Nant Brioche, French Bread and Whole Wheat products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the name and place of business of the responsible party is not declared in accordance with 21 CFR 101.5.
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 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Failure to implement lasting corrective action 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.
In addition, we have the following comments:
1. Your French Bread and Whole Wheat products do not appear to include complete statements of identity in accordance with 21 CFR 101.3. For example:
- Your French Bread product should include a statement of identity in accordance with 101.3. Your label displays a vignette of a loaf of French Bread where one would expect to see the statement of identity, and the ingredient statement begins with the statement “French Bread Ingredients”; however, these label components are not adequate substitutes for a statement of identity on your product label.
- Your Whole Wheat product does not appear to bear a complete statement of identity in accordance with 21 CFR 101.3. Your statement of identity is “Whole Wheat”; however, as this is not a complete statement of identity for a baked good, the identity of your product is unclear. If this product is a bread, roll, or bun, we note that the product does not meet the standard under 21 CFR 136.180 for whole wheat bread, rolls, and buns. Under the standard, the dough must be made exclusively from whole wheat flour; this product contains whole wheat and enriched wheat flours.
2. The label of your Strawberry Roll product displays a vignette of strawberries; this vignette, in combination with the name of your product, Strawberry Roll, suggests that your product includes strawberry ingredients; however, the label does not declare any strawberry ingredients. You must ensure that your ingredient list includes a complete list of ingredients to be in compliance with 21 CFR 101.4.
We request that you notify this office in writing, within 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, plans on how you plan to protect food products from possible contamination, and/or any other useful information that would assist us in 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 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 Brenda L. Reihing, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have questions about this letter, please contact Compliance Officer Brenda Reihing at 425-302-0429.
Charles M. Breen
Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560