Seattle Roll Bakery 1/25/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
January 25, 2012
RETURN RECEIPT REQUESTED
In reply refer to: Warning Letter SEA 12-11
Mr. Huy T. Duong, Owner
Seattle Roll Bakery
9828 16th Avenue SW
Seattle, Washington 98106-2829
Dear Mr. Duong:
The Food and Drug Administration (FDA) conducted an inspection of your bakery located at 9828 16th Avenue SW, Seattle, Washington, on August 20, 21 and 23, 2011. During the inspection, the FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These violations cause the food products produced in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.
Additionally, our review of the labeling for your Ban Tieu, Chao Quay and Vietnamese Sandwich revealed that these products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. §343] and the regulations for food labeling at Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov
Your significant violations are as follows:
1. As required by 21 CFR 110.35(c), you must not allow pests in any area of a food plant. Effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. However, our investigators observed the following evidence of a lack of pest control:
a. On September 20, 2011, a live rodent was observed three times in the dough preparation area, including inside the top drawer of the dough preparation table during production of sandwich rolls.
b. On September 21, 2011, two live rodents were observed in the dough preparation area.
c. On September 23, 2011, one dead rodent was caught in a snap trap in the SW corner of the dough preparation room.
d. On September 20, 2011, four decaying rodent carcasses were observed in the two bins below the dough preparation table.
e. Numerous apparent rodent excreta pellets (REPs) were observed throughout your firm:
i. 12 REPs in the dough preparation area, including under the dough cutter, under the ice machine, and inside three drawers directly beneath the dough preparation table;
ii. 10 REPs in the closest space adjacent the toilet facility;
iii. 8 REPs under the bread packaging table; and
iv. 20 REPs within the three drawers of the dough preparation table.
f. Flies were observed throughout the facility, including on containers of soaking vegetables, and on clean stored containers above the 3-compartment sink in the dough preparation area, inside the dry goods storage room, and the sandwich preparation area.
g. Flies were observed on food contact surfaces (FCS) and uncooked food products during the production of sandwich rolls, including on the FCS of a scale used for weighing dough, on dough trays, on the dough preparation table, and on a bowl of flour.
h. Live cockroaches were observed in the dough preparation area and packaging area on clean FCSs, including two cockroaches on a colander stored above the 3-compartment sink.
i. Dead cockroaches were observed on the surface of the coffee preparation table and on the floor next to this table in the packaging area.
We note that the drawers and bins beneath the dough preparation table where the carcasses of the rodents and a live rodent were observed, were removed from the facility before the conclusion of the inspection.
2. As required per 21 CFR 110.20(b)(7), you must provide adequate screening and protection against pests. Our investigators observed the front door of your facility left open on 9/20/2011 from 11:00 A.M. until 4:00 P.M., and on 9/23/2011 from 2:30 P.M. until 4:00 P.M., and observed flies entering the facility. Additionally, we observed a rodent disappear into a hole inside a wall behind the chimney, across from the dry goods storage.
3. As required by 21 CFR 110.80(b)(5), work-in-process shall be handled in a manner that protects against contamination. However, our investigators observed the following:
a. A fly strip with insects adhered to it was directly over the stove. Meat for sandwiches was being cooked on the stove in an open pan below the fly strip.
b. Finished sandwich rolls were touching a soiled tape dispenser on the packaging table.
c. Open bowls and bags of ingredients were inside the dry goods storage room. At least 12 flying insects were directly over exposed product.
d. Old cooking oil was used to grease the dough cutter. Oil was dripping down the sides of the cutter that was used during production of sandwich rolls.
e. A container of soaking carrots was partially placed beneath a utensil basket in the wash compartment of the 3-compartment sink. The basket held cleaning brushes and scouring pads.
f. A colander of julienned radishes was placed directly on the step of a soiled step ladder.
g. An employee's partially consumed meal was on the dough preparation table within 6 inches of rolling pins and donut cutters during production of sandwich rolls.
We note the fly strip had been removed before the conclusion of the inspection.
4. As required by 21 CFR 110.35(d), you must clean all food-contact surfaces, including utensils and food-contact surfaces of equipment, as frequently as necessary to protect against the contamination of food. However, our investigators observed the following during the inspection:
a. Food residue was on the food contact surface of the dough cutter and julienne cutter used to cut ready-to-eat carrots and radishes.
b. Scissors with soiled handles were in a pan of cooked meat. Meat was being cut with the scissors.
c. Food residue on non-food contact surfaces of the interior of the dough storage cabinet.
5. As required by 21 CFR 110.35(b)(2), toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. However, we observed the following during their inspection: chemicals, such as texture spray, equipment lubricant and cleaning aids, stored at various locations throughout the dough preparation area. Specifically:
a. Orange peel spray texture was next to the sink.
b. (b)(4) and a can of butane were stored in a workbench beneath the julienne slicer.
c. (b)(4) and a tub of drywall were on a shelf behind an unused dough mixing machine.
6. As required by 21 CFR 110.40(a), all equipment and utensils must be designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils must preclude the adulteration of food with any contaminants. However, a heavily worn brush was used to oil the baguette trays and a raw wood "hoe" was used to push/pull sandwich rolls during packaging.
7. As required by 21 CFR 110.20(b)(5), you must provide safety-type light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage. However, missing lights and unshielded or improperly shielded lights were in the dough preparation area, over exposed sandwich rolls in the bread packaging area, and unshielded lights were in the packaging area.
8. As required by 21 CFR 110.35(a), you must maintain buildings, fixtures, and other physical facilities in a sanitary condition and keep them in repair sufficient to prevent food from becoming adulterated. However, our investigators observed the following during the inspection:
a. Grease and food residue was on the floor throughout the dough preparation area, especially around the fryer.
b. Grease and food residue was on non-food contact surfaces of storage racks, dough cabinet, fryer, stove, baking trays, step stool, and other surfaces.
c. The dispensing knobs of the paper towel dispensers in the dough preparation area and toilet facility were visibly soiled.
9. As required by 21 CFR 110.80(b)(7), equipment, containers, and utensils used to convey, hold, or store food must be handled in a manner that protects against contamination. However, a clean metal bowl and two colanders were stored on the counter of the hand-wash sink, whereby they could become contaminated from splashing during hand-washing. Additionally, baguette trays were stacked on top of a visibly soiled waste bin and also on top of the preparation table next to the fryer.
10. As required by 21 CFR 110.10(b)(3), all persons working in direct contact with food, food-contact surfaces, and food-packaging materials must wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable organisms) in an adequate hand-washing facility at any time when the hands may have become soiled or contaminated. However, our investigators observed the following during the inspection:
a. An employee touched the visibly soiled waste bin with his bare hands, and then went directly back to handling dough without washing his hands.
b. An employee was observed using the julienne press to cut radishes, then handling the dirty step ladder to put it away, and then going directly to the stove to cook meat used in the sandwiches without washing her hands or changing gloves.
11. As required by 21 CFR 110.37(e), a food production plant shall be equipped with adequate sanitary directions, however, our investigators observed there were no hand-wash signs directing employees to wash their hands at either of the hand-wash sinks in the toilet facility or the dough preparation area.
12. As required by 21 CFR 110.10(b), all persons working in direct contact with food, food contact surfaces, and food-packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. However, our investigators observed the following during the inspection:
a. A hat and box of personal medicine was on the slicer in the sandwich preparation area and the baker's lunch eggs were on the dough preparation table.
b. The baker and an employee were observed with exposed hair beneath their caps during production of sandwich rolls and sandwich ingredients, and an employee was packaging rolls without a hair restraint. The owner was processing dough without a hair or beard restraint, and without removing his jewelry or wearing gloves over his long fingernails.
c. An employee touched the visibly soiled waste bin with his bare hands, and then went directly back to handling dough without washing his hands.
d. An employee was observed using the julienne press to cut radishes, then handling the dirty step ladder to put it away, and then going directly to the stove to cook meat used in the sandwiches without washing her hands or changing gloves.
e. Two employees were observed rinsing their hands in the 3-compartment sink and not using soap. In addition, access to the hand-wash sink in the dough preparation area was blocked at the start of the inspection by rolling racks.
13. As required by 21 CFR 110.20(a)(1), you must remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the facility buildings or structures. Specifically, your firm lacks a dumpster or waste containers for waste disposal. On September 20, 2011, at least twenty paper bags and five cardboard cases of garbage, including open bags of food waste, were along the fence towards the back of the facility. The bags were within 3 feet of the two back doors to the facility.
14. As required by 21 CFR 110.20(b)(4), your plant must be constructed in such a manner as to allow it to be adequately cleaned and kept clean. However, our investigators observed that your facility had rough and difficult to clean surfaces on the walls, floors, and wall/floor junctures within the dough preparation area. The floor/wall juncture on the south wall exhibited exposed insulation foam; and that the back cooler used for dough proofing is housed in a room with exposed wall studs and plywood.
15. Your Ban Tieu, Chao Quay and Vietnamese Sandwich products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4 as follows:
a. Banh Tieu and Chao Quay: Sugar and oil were observed being used to manufacture the products; however, you fail to list the ingredients on the finished product label.
b. Vietnamese Sandwich: Sugar, oil, "Butter" emulsion and dough conditioner were used to manufacture the bread used for this product; however the ingredients and sub-ingredients failed to be declared on the finished product label.
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 [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 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.
16. Your Ban Tieu, Chao Quay and Vietnamese Sandwich products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the products fail to bear a label with the complete place of business, street address, city, state and zip code of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
17. Your Ban Tieu and Chao Quay products are misbranded within the meaning of 403(e)(2) in the labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count in accordance with 21 CFR 101.105.
18. Your Ban Tieu, Chao Quay and Vietnamese Sandwich 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 the nutrition facts information on the package labels as required by 21 CFR 101.9.
These observations are further detailed in the Form FDA 483 that was discussed with you at the close of the inspection. At the close of the inspection, you indicated a verbal commitment to voluntary corrections that would be made as a result of the observations documented by FDA Investigators.
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.
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.
Please send your reply to the Food and Drug Administration, Attention: Heidi Marks, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Ms. Marks at (425) 483-4862 or via email at email@example.com
Charles M. Breen