Han Yang Oriental Food Mfg 4/11/14
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
April 11, 2014
In reply refer to Warning Letter SEA 14-11
Jung C. Choi, Owner
Hyun S. Choi, Owner
Han Yang Oriental Food Mfg
3819 94th Street SW
Lakewood, Washington 98499-4419
Dear Mr. and Mrs. Choi:
On November 4 through November 27, 2013, investigators from the United States Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 3819 94th
Street SW, Lakewood, Washington 98499. During the inspection, FDA investigators collected finished product samples and environmental samples from multiple areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of a human pathogen Listeria monocytogenes
)in your facility. In addition, FDA found that your facility has serious violations of the Current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. Based on FDA’s analytical results for the environmental samples and inspectional findings documented during the inspection, we have determined that your ready-to-eat rice cake and tofu products are 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 they were prepared, packed,
or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov
FDA laboratory analysis of samples INV834610 and INV834611, collected on November 6, 2013, and November 18, 2013, respectively, confirmed six (6) environmental swabs were positive for L. monocytogenes. The locations of these positive swabs are significant in that they were found in locations that have a likelihood of a direct route of contamination into food. Specifically, the positive swabs were collected from the floor of the finished product packing room and from the wheels of a metal cart used throughout the facility to transport in-process product. Finished, ready-to-eat rice cakes were observed uncovered on a table approximately three feet from the floor area that tested positive. In-process rice was observed transported on the metal chart that tested positive during the inspection. The presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment. It can proliferate in food processing facilities without proper controls, where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, an atypical foodborne illness of major public health concern due to the severity of the disease, its high case-fatality rate, long incubation, and predilection for individuals with underlying conditions.
FDA investigators also observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:
1. Your firm failed to ensure work-in-process is handled in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). Specifically, our investigators observed:
a. Employees handling non-food contact surfaces and subsequently contacting ready-to-eat product and food contact surfaces without washing hands or changing gloves.
i. Employee wearing gloves touched a soiled power switch for the rice grinder before using his hands to manipulate soaked rice into the grinder hopper without washing or changing his gloves.
ii. Employee wearing gloves touched the sweet rice mixer’s soiled power switch and then used his gloved hands to knead and flatten balls of sweet rice without washing or changing his gloves.
iii. Employee wearing gloves touched soiled power switches and a rice extruder wheel handle that was soiled and rusted. The employee then proceeded to touch soaked rice while feeding it into extruder hopper without washing or changing his gloves.
b. An employee placed a metal slicer with soiled plastic handle directly on top of uncovered, ready-to-eat rice cakes. The plastic handle had visible damage and discoloration.
c. An uncovered bowl of rice flour was observed sitting on a shelf in the rice steaming area directly below a wall-installed hand sanitizer station. An employee was observed using the hand sanitizer station while the uncovered bowl of ground rice was positioned below.
2. Your firm failed to handle and maintain equipment, containers, and utensils used to convey, hold, or store food in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). Specifically, our investigators observed an employee placing clean tofu press trays on the wet floor of your tofu room.
3. Your firm failed to take all reasonable precautions to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR 110.80. Specifically, our investigators observed an employee exiting the building, walking across wet pavement, and returning to the packing room, where finished product is packaged, without cleaning or changing footwear.
4. Your firm failed to ensure your plant is constructed in such a manner that floors may be adequately cleaned, kept clean, and kept in good repair and in such a manner as to prevent condensate from contaminating food and food-contact surfaces, as required by 21 CFR 110.20(b)(4). Specifically, our investigators observed:
a. Condensate on the ceiling of the facility directly above an open metal tofu cooling tank containing several bricks of fresh ready-to-eat tofu in water and open (b)(4) buckets of ready-to-eat-tofu.
b. The rice room floor was damaged with exposed concrete aggregate and deep gouging. Water splashing and standing water with product residue were observed on the floor of the rice room during production hours.
5. Your firm failed to keep toilet facilities in good repair at all times, as required by 21 CFR 110.37(d)(2). Specifically, our investigators observed that a toilet in the employee restroom was leaking water from the top tank when flushed, causing water to collect on the floor near the base of the toilet.
6. Your firm failed to ensure all food manufacturing, including packaging and storage, is conducted under such conditions and controls as are necessary to minimize the potential for growth of microorganisms, or for the contamination of food, as required by 21 CFR 110.80(b)(2). Specifically, our investigators observed:
a. A fan box with soiled grating in the Product Cooler Room was blowing in the direction of open packages of ready-to-eat sliced rice cakes.
b. Two open vats containing congealing tofu curd placed directly underneath a soiled air circulation grate installed in the ceiling of the tofu room.
c. A tray of cooked eggs for use in ready-to-eat Korean sushi was observed stored at ambient temperature in the employee break room for at least 3 hours and 45 minutes.
Furthermore, FDA laboratory analyses of samples INV834610 and INV834611, collected on November 6, 2013, and November 18, 2013, respectively, confirmed thirty eight (38) environmental swabs were positive for L. innocua, a non-pathogenic Listeria species. The positive swabs were collected from locations throughout the facility, including on food-contact surfaces such as the rice grinder. Additionally, FDA laboratory analyses of sample INV834612, collected on November 18, 2013, confirmed one (1) composite was positive for L. seeligeri, another non-pathogenic Listeria species. The positive composite swab was collected on your finished, ready-to-eat rice cake product. The presence of indicator organisms such as L. innocua and L. seeligeri is significant in that it demonstrates inadequate sanitation practices within your facility and manufacturing conditions that may reasonably allow for contamination of food.
We acknowledge receipt of your letter dated December 5, 2013, addressing the observations made during the inspection. Your response indicates you have initiated and promised corrections to the observations. The adequacy and implementation of these corrections will be verified on the next scheduled inspection. However, your response is not fully adequate. Your response did not address the findings of L. monocytogenes in the facility and your corrective actions to ensure elimination and prevention of recurrence of this pathogen. Additionally, your response failed to provide adequate timeframes, documentation, or details on issues such as employee training, cleaning schedules, and the contract to repair the rice room floor. Your response stated that you will have completed and fully implemented a Standard Operating Procedure (SOP), inclusive of a Plant Sanitation Program and an Employee Training Program, by April 2014. While we acknowledge this promised correction, we note that you have promised to train employees on better sanitation practices in previous correspondence with our office. You response failed to adequately state how your firm will prevent the recurrence of the observations listed in the Form FDA 483.
The above violations are not meant to be an all-inclusive list of violations that may exist at your facility or with respect to your products. It is your responsibility to ensure that your facility and your products are in compliance with the Act and all applicable regulations. Your firm should take prompt action to correct the violations addressed in this letter and to implement procedures to prevent such violations from recurring. Failure to do so may result in enforcement action by FDA without further notice.
Please respond in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation (such as, but not limited to, photographs, purchase orders, revised Sanitary Standard Operating Procedures (SSOPs), etc.) of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this letter.
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
Please submit your response to Jessica L. Kocian, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Jessica Kocian at (425)-302-0444.
Ann M. Adams, PhD
Acting District Director
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560