Inspections, Compliance, Enforcement, and Criminal Investigations
Pacific Northwest Tofu, LLC 11/8/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
November 8, 2012
In reply refer to Warning Letter SEA 13-05
Tony Dinh, Owner
Pacific Northwest Tofu, LLC
6113 NE 92nd Drive
Portland, Oregon 97220
Dear Mr. Dinh:
The Food and Drug Administration (FDA) conducted an inspection of your firm located at 6113 NE 92nd Drive, Portland, Oregon, on August 20-29, 2012. During the inspection, the FDA investigator documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR Part 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. 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. Your firm failed to handle work in-progress in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). Specifically, we observed:
a. On August 20, 2012, blocks of unpackaged ready-to-eat tofu were submerged in one end of a tank of water with soiled utensils submerged at the other end. Water from a faucet above the soiled utensils was flowing into the tank and the direction of flow of the water within the tank was from the soiled utensils toward the tofu and out over the edge at the tofu end of the tank;
b. On August 20, 2012, condensate on a metal plate positioned below the soybean soaking tank was dripping down and landing into a bin of soaked soybeans. These soybeans were observed to be processed into firm tofu later in the day; and
c. On August 20, 2012, condensate on a hand wheel below the soybean soaking tank was dripping down and landing in a vat of ground soybean paste. This paste was observed to be processed into firm tofu later in the day.
2. Your firm failed to ensure that employees wash and sanitize their 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). Specifically, we observed:
a. On August 20, 2012, a production employee wiped his forehead with the back of his arm and hand, touched his apron with his hands, and handled a plastic water nozzle with both hands. Without washing his hands, he then handled a batch of tofu while cutting it into ready-to-eat portions; and
b. On August 21, 2012, a production employee used his hand to touch his arm and sleeve of his shirt. Without washing his hands, he then pulled blocks of ready-to-eat tofu from the north tofu soak tank and placed them in plastic-lined 5-gallon buckets for delivery.
3. Your firm failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food-contact surfaces, as required by 21 CFR 110.35(a). Specifically, we observed four instances on August 21, 2012, of employees cleaning food-contact utensils while resting the utensils on the floor or against clothing.
4. Your firm failed to handle raw materials to ascertain that they are clean and suitable for processing into food, as required by 21 CFR 110.80(a)(1). Specifically, on August 20, 2012, we observed an employee scoop anti-foam agent out of a drum with an unsealed opening at the top, and add it to a vat of soybean and water paste. A swirl of unidentified black material was observed on the white anti-foam agent inside the drum.
5. Your firm failed to ensure that employees remove hand jewelry which cannot be adequately sanitized during periods where food is being manipulated by hand, as required by 21 CFR 110.10(b)(4). Specifically, we observed on August 21, 2012, an employee wearing a rubber bracelet with engraved lettering. The employee reached into a tank filled with water and blocks of tofu, submerging the bracelet in the water, while removing over fifty blocks of ready-to-eat tofu and placing them in packages.
6. The design of utensils does not allow for proper cleaning, as required by 21 CFR 110.40(a). Specifically, we observed on August 20, 2012:
a. An employee used a device made of multiple wires twisted together and attached to a small plastic cup to scoop anti-foam agent out of a plastic drum and add the agent to a vat of soybean and water paste. The utensil is not disassembled for cleaning, and the metal wires are twisted together in such a way to make parts of the utensil handle uncleanable without disassembly; and
b. An employee used a red plastic strainer bowl that had a crack in its side which was held together with plastic ties, to remove liquid from a vat of congealing soybean paste. The ties came in direct contact with the paste during the liquid removal process. Soybean paste residue was observed on the ties after the strainer had been cleaned following production at the end of the day.
7. Your facility is not constructed in such a manner as to allow floors to be adequately cleaned and kept clean and in good repair, as required by 21 CFR 110.20(b)(4). Specifically, we observed an approximately 6 foot by 20 foot area of the floor directly below the tofu processing line with sections of exposed concrete aggregate, and covered in water and soybean waste material throughout the processing period. Employees were observed to spray this area of the floor with water repeatedly during the processing period, causing water vapor to rise into the air in the vicinity of exposed in-process tofu. Additionally, water and soybean waste pooled in pits of exposed concrete aggregate that could not flow into the installed floor drain systems due to the depth of the pits.
8. Your firm failed to maintain buildings and fixtures in repair sufficient to prevent food from becoming adulterated, as required by 21 CFR 110.35(a). Specifically, we observed on August 20, 2012:
a. A metal light box with chipping paint and rust hanging directly over two metal tofu cooling tanks containing ready-to-eat blocks of tofu;
b. An approximately 3 foot by 5 foot area of apparent mold on the ceiling of the facility above the soybean soak tank and roller/extractor; and
c. An approximately 12 inch by 12 inch section of insulation hanging from the ceiling on the west side of the processing area, approximately 20 feet above two large open metal vats. An employee took one of the metal vats from below the hanging insulation and used it to collect soybean extract from the roller-extractor without washing the vat.
9. Your firm failed to maintain effective measures to exclude pests from processing areas, as required by 21 CFR 110.35(c). Specifically, we observed on August 20, 2012, twenty-three (23) dead apparent fruit flies on the top of the drum of anti-foam agent, within 8 inches of the unsealed opening.
10. Your firm failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, we observed multiple gaps along the bottom of the northwest, southwest, and southeast loading dock doors.
11. Your firm failed to provide sufficient space for storage of materials as necessary for the maintenance of sanitary operations and the production of safe food, as required by 21 CFR 110.20(b)(1). Specifically, we observed on August 20, 2012, discarded cardboard boxes, unused equipment, machinery, furniture, and pallets stored against the wall along the east wall in the northeast corner of the processing room. Bags of soybeans were stacked next to these materials without adequate space to allow effective cleaning and pest monitoring.
12. Your firm failed to 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, we observed on August 20, 2012, within 10 feet of your northwest loading dock doors: ten (10) live apparent flies flying around and landing on soybean waste material stored in five (5) uncovered drums; a mattress and box spring leaning against the wall of the facility; and parts of five (5) discarded wooden pallets on the ground.
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). 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.
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.
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 plans on how you plan to protect food products from possible contamination, actions performed to control unauthorized entrance of pests, 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, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Ms. Marks at (425) 302-0418 or in writing at the address above.
Charles M. Breen
cc: Oregon Department of Agriculture
Food Safety Division
635 Capital Street NE
Salem, Oregon 97301