The FDA issued a warning letter in recent days regarding an inspection 18 months ago at a sprout and tofu facility where federal officials found live rodents and cockroaches, as well as Listeria bacteria.
In the letter, regional officials with the Food and Drug Administration told Steven Seeto that his company Fortune Food Product Inc. is in violation of two different sets of federal regulations because it is a “mixed-type facility.” The Chicago company grows fresh sprouts from mung beans, which falls under the produce safety rule, and it produces tofu and soybean noodles, which makes it subject to food production facility regulations.
Violations observed during a January 2018 inspection, in addition to the live rodents and cockroaches, include employees scooping sprouts up off the floor and preparing them for sale. The company’s officials and employees admitted to violations during the inspection, according to the warning letter.
“You then explained that you had never inspected your water system to identify conditions that are likely to introduce hazards to your sprout operations,” according to the warning letter that cites various water-related problems.
“. . . You must provide hand washing facilities that are adequate and convenient. . . . the handwashing sinks in the tofu production room lacked soap and hand towels. Your firm’s employees were observed using their bare hands to pack spicy tofu into clear plastic bags. . . .Your response letter dated Feb. 22, 2018, did not address the failure to provide soap and towels at the tofu production room hand washing stations.”
Inspectors also documented dirty equipment, failure to conduct mandatory testing of sprouts, water and the facility environment, and numerous employees violating food safety laws.
Seeto and Fortune Food Multiple also have multiple labeling violations, including failure to list all ingredients and inaccurate nutritional information.
In a somewhat unusual move, the FDA warning letter included specific details on potential seizure of products. The agency has standard language used in all warning letters explaining its authority to seize food:
“We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.”
In the fortune Food warning letter, the FDA included the following specifics:
- During our inspection, you stated that you did not use a seed treatment on your mung beans prior to sprouting. In your response dated February 22, 2018, you state that you now treat your mung beans with (redacted by FDA). You also submitted a document titled “SANITARY CERTIFICATE” which includes a statement that the subject seed lot was tested by (redacted by FDA) and determined negative for Salmonella, Listeria monocytogenes, and E. coli O157, and referred to the provision allowing sprout growers to rely on prior treatment of seeds to fulfill this requirement. The document you provided is not a Certificate of Conformance, as permitted under 21 CFR 112.142(e)(2) because it does not indicate that the seeds have been treated for pathogen reduction using a scientifically valid method to reduce microorganisms of public health significance prior to your receiving them, and it does not state that treated mung bean seeds were handled and packaged following the treatment in a manner that minimizes the potential for contamination. Furthermore, a tag found on the bags of mung beans indicates that the seeds have not been subject to any treatment. 21 CFR 112.142(e)(1) requires that you must treat your seeds for sprouting with a scientifically valid method to reduce microorganisms of public health significance. Based on your response, we cannot evaluate whether you have adequately implemented a seed treatment. If you have, we request more information about your seed treatment process, including documentation of your scientifically valid treatment of mung bean seeds to reduce microorganisms of public health significance in the mung bean seeds. A “scientifically valid” method is an approach that is based on scientific information, data, or results published in, for example, scientific journals, references, text books, or proprietary research.
- During our inspection, an employee who oversees your operation stated that your firm did not conduct any training of your sprout operation employees. 21 CFR 112.21(a) requires that you provide adequate training at sufficient frequency to all personnel who handle covered produce or food contact surfaces. In your response letter dated February 22, 2018, you state that you will be implementing training soon. Additionally, you provided a training record for training in the use of hairnets and gloves. You did not provide any other evidence such as a training schedule, training logs, or training forms to indicate additional necessary training will be taking place.
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