Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
May 8, 2015
In reply refer to Warning Letter SEA 15-15
Miran Kim, Owner
KJ3, Inc., dba Rainier Sprouts
11028 Portland Avenue East
Tacoma, Washington 98445
Dear Ms. Kim:
The United States Food and Drug Administration (FDA) conducted an inspection of your sprouting operation, located at 10310 Vickery Avenue East, Tacoma, Washington, on December 9, 11, 15, and 22, 2014. During the inspection, we documented insanitary conditions and practices that render your mung bean and soybean sprouts 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 or whereby they may have been rendered injurious to health. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions in your sprouting operation at the time of the inspection. Your firm submitted corrective actions dated January 4, 2015, relative to the FDA-483 findings. The following conditions and practices have not been adequately addressed as follows:
- Condensate was observed dripping from the ceiling directly above the hand wash sink in the packaging room during the packaging of mung bean and soybean sprouts and dripping from the ceiling in front of the main door leading into the mung bean growing room. Condensate may foster the growth, contribute to the spread, and/or allow for the development of harborage sites for pathogens, such as Listeria monocytogenes.
You promised you would fix the problem as soon as possible once the building owner returns from Korea. However, you did not commit to discontinuing the production of sprouts until it could be fixed. Please provide us with details and documentation that the problem has been fixed.
- Rodent excreta pellets were observed throughout your sprouting operation including areas along the floor-wall junction underneath the mung bean growing chamber, along the top of the wall heating unit, along the north wall of the mung bean growing room, and on the floor underneath the northwest corner of the mung bean growing chamber number 6. These findings demonstrate that you are not adequately controlling pests in your sprouting operation. Since rodents are known to harbor and spread pathogens, the insanitary conditions observed at your sprouting operation render the food produced at your sprouting operation adulterated.
Your firm’s response indicates that you will take steps to frequently clean your equipment and place mouse traps around your sprouting operation. Additionally, you have indicated that your firm has fixed a gap that was present in the floor-door junction of the main door leading into the mung bean growing room. You did not provide documentation demonstrating that you have resolved the problem. For example, in your response you could have included mouse trap monitoring records to demonstrate that the issue had been resolved. We will ascertain the adequacy of your corrective action during our next inspection.
- Residues and gouges were observed throughout your conveyor equipment, specifically, black residues were observed inside the pitted portions of the conveyor belts leading into the sprout dryer and sprout packing station; yellow slime residues were observed on the food contact surface side of the metal conveyor chain located underneath the sprout dryer; sprout residues were observed inside of the plastic cord used to tie together sections of the metal conveyors; sprout and black residues were observed on the underside of the plastic strips on the conveyor exiting the wash tank, the conveyor leading into the sprout dryer, and the conveyor onto the packaging station; and gouges and cuts were observed on the conveyor belt used to transport mung bean and soybean sprouts from the wash tank to the dryer. Since your conveyors come into direct contact with your in-process and finished ready-to-eat mung bean and soybean product, the maintenance and cleaning of the equipment is pertinent. These findings demonstrate that your cleaning and sanitizing practices are inadequate.
Your firm’s response indicates that you will take steps to replace and clean your soiled and broken equipment. While these actions may result in the immediate cause of these deviations being corrected, there is no indication that a change in procedure is being enacted to ensure that these maintenance matters will be corrected in an on-going fashion. Specifically, your response failed to address the changes you will make to your firm’s sanitation procedures to prevent similar deviations from recurring.
The above violations are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of the Act and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Note that FDA laboratory analyses of your finished, bagged ready-to-eat soybean sprouts, confirmed positive for Listeria welshimeri, a non-pathogenic Listeria species. The presence of Listeria welshimeri is significant in that it further demonstrates that the cleaning and sanitation practices within your sprouting operation are inadequate and may reasonably allow for contamination of sprouts. Additionally, the presence of this organism indicates that the conditions are conducive for pathogenic Listeria monocytogenes to be present in your sprouting operation.
Information on proper handling and controls for sprout manufacturing can be found in our Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouted Seeds, (located online at http://www.fda.gov/food/guidanceregulation/ucm120244.htm) and Guidance for Industry: Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production (located online at http://www.fda.gov/food/guidanceregulation/guidancedocuments regulatoryinformation/produceplantproducts/ucm120246.htm), both dated October 27, 1999. Also, the University of California at Davis, in cooperation with FDA, developed a series of online videos related to sprout safety that can be found at: http://postharvest.ucdavis.edu/libraries /video/. The documents and online videos are considered guidance and are designed to assist you in complying with the Food, Drug, and Cosmetic Act.
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 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.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter describing the specific steps you have taken to correct the noted violations, and to prevent these violations, or other similar violations, from occurring again. You should include documentation of corrective actions you have taken to date (e.g., implementation of an effective pest control program to continually monitor for pests or rodents in processing areas, improvements to your cleaning and sanitation program for your equipment). If your firm’s planned corrections will occur over time, please state the reason for the delay and include a timetable for implementation of those corrections.
Your reply should be sent to the following address: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021 to the attention of Maria P. Kelly-Doggett, Compliance Officer. If you have any questions regarding any issues in this letter, please contact Compliance Officer Maria Kelly-Doggett by telephone at 425-302-0427.
Miriam R. Burbach
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560