Inspections, Compliance, Enforcement, and Criminal Investigations
Jang Soo Farm Inc. dba Rainier Sprouts, Inc. 12/28/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
December 28, 2011
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-10
Mr. Mal S. Sin, President
Jang Soo Farm, Inc.
dba Rainier Sprouts
10310 Vickery Avenue East
Tacoma, Washington 98446-3653
Dear Mr. Sin:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your sprout growing facility located at 10310 Vickery Avenue East, Tacoma, Washington, on August 30-31, September 2, 6-9, and 26, 2011, in response to industry-wide surveillance for conditions that may promote pathogen contamination of sprouts. During the inspection, FDA collected two samples -- consisting of various mung beans, rodent excreta pellets, rodent hair, old nesting material, and rodent-gnawed packaging material -- from your facility that confirmed the presence and activity of rodents and insects. Our investigators documented insanitary conditions and practices that contribute directly or indirectly to possible contamination of your sprouts with filth and pathogens. Accordingly, sprouts grown in your facility 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)] because they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the Act through links on FDA’s homepage at www.fda.gov.
We acknowledge receipt of your response letter dated October 10, 2011. The adequacy of these corrective actions and their implementation will be evaluated during our next inspection.
The following insanitary conditions and practices were observed:
1. Food contact surfaces must be thoroughly cleaned and sanitized to avoid serving as a source and route of filth and pathogens into food; however, food contact surfaces were found to be insanitary as evidenced by:
a. The large shovel used to unload the mung bean sprouts from the incubators and to unload the totes of mung beans was observed lying on the ground in front of an incubator during unloading of the sprouts. The shovel was later observed in use to finish unloading the incubator. The shovels are also stored hanging directly against an insanitary wall, and not sanitized before use. We acknowledge that you stated that you had instructed employees to now clean and sanitize the shovels before use and allow them to air dry; and in your response letter you additionally stated that they are cleaned with bleach (b)(4) and that when they are hung on the wall they are not allowed to touch the wall. The adequacy of these corrective actions and their implementation and continued sanitation will be evaluated during our next inspection.
b. Fibrous blankets are used to cover totes of sprouts in the staging area to protect them from light. These blankets came in direct contact with the ready to eat sprouts and were neither regularly cleaned, nor fully cleanable. We acknowledge that prior to the end of the inspection you had removed the blankets and replaced them with black plastic covers and that you promised to clean and sanitize these covers on a daily basis; and in your response letter you note that you sanitize the plastic covers after each day’s work. The adequacy of these corrective actions and their implementation and continued sanitation will be evaluated during our next inspection.
2. Employees may cross-contaminate the sprouts directly and indirectly, as evidenced by:
a. The hand-washing sinks in both the processing area and the mung bean incubating room have drains that do not extend to the floor drain, but rather extend horizontally out from under the sink and drain directly onto the floor and wall. Dirty water dropping from this height can create an aerosol that could splash onto employees’ clothes or equipment that may be in the area which may later be exposed to food. We acknowledge that the drain pipe was extended to reach directly into the floor drain prior to the end of the inspection.
b. Within a few feet of open totes of mung mean sprouts and open buckets of mung beans, were employee’s personal belongings, as well as break-time equipment (microwave, refrigerator, coffee maker, hot plate) and table for eating. The bustle of these activities may allow insanitary foreign material to get into the totes of beans and sprouts. We acknowledge that you promised to remove the break room equipment from the processing area and find a different location for employees to use on break. The adequacy of these corrective actions and their implementation will be evaluated during our next inspection.
3. Sprouts may be cross-contaminated by poor facility conditions that allow filth or pathogens to find their way into food, as evidenced by:
a. Live rodents, rodent excreta pellets, and urine markings were found on bags of stored raw mung beans. Bags of stored raw mung beans were found with gnaw holes. We acknowledge that prior to the end of the inspection, the mung bean storage room was cleaned of filth and re-organized, the walls and ceiling resurfaced, and the rodent-gnawed and rodent-marked bags were voluntarily destroyed at the local landfill. We acknowledge that you promised to implement a new warehousing plan that provides for less congestion and easier cleaning. The adequacy of these corrective actions and their implementation and continued sanitation will be evaluated during our next inspection.
b. Rodent excreta pellets were found on the floor of the finished product cooler and trash was observed under the pallets on which finished product is stored. We acknowledge that prior to the end of the inspection, the cooler was cleaned and maintenance performed to seal holes and gaps that may have provided pest entry. We acknowledge that you promised to maintain the cooler with periodic cleaning and maintenance checks. The adequacy of these corrective actions and their implementation and continued sanitation will be evaluated during our next inspection.
c. Hardware connecting hoses to the track system directly above the soy bean sprouting buckets was covered with flaking rust. We acknowledge that you stated you had new hose hardware on order and promised to replace it; and in your response letter that you have already replaced the hardware. The adequacy of these corrective actions and their implementation will be evaluated during our next inspection.
d. Condensation had collected on the hoses and electrical cords of the track watering system and was observed dripping directly into buckets of soy beans and soy sprouts in progressive stages of growth. These hoses were not clean and were covered with apparent mold. We acknowledge that prior to the end of the inspection the hoses had been replaced with new hoses of a different, smoother design that you stated will allow for more effective cleaning. The adequacy of these corrective actions and your continued sanitation will be evaluated during our next inspection.
e. The fan blades in the soy bean sprouting room were not cleaned and had a build-up of filth across the blades, which extend over the open buckets of soy sprouts. We acknowledge that the fan blades were cleaned prior to the end of the inspection, and that you promised to add these to the cleaning schedule. The adequacy of these corrective actions and your continued sanitation will be evaluated during our next inspection.
At the inspection, FDA recommended that you change your method of seed treatment because your practice was not in accordance with FDA recommended guidance of using 20,000 ppm calcium hypochlorite solution. We observed that you were only using (b)(4) ppm (b)(4). We acknowledge that by the conclusion of the inspection, you had purchased (b)(4) brand hypochlorite and were soaking the mung and soy bean seeds in 20,000 ppm solution for (b)(4) minutes. The adequacy of these corrective actions and their continued implementation will be evaluated during our next inspection.
The above items are not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with the applicable laws and regulations administered by FDA. You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days of receipt of 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 the corrective actions you have taken to date (e.g., implementation of an effective pest control program to continually monitor pests or rodents in processing areas, improvements to your sanitation program that incorporates adequate cleaning and sanitation of your equipment, etc.). If your planned corrections will occur over time, please state the reason for the delay and include a timetable for implementation of those corrections.
During the inspection, our investigators provided you a copy of the Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouted Seeds, and Guidance for Industry: Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production, both dated October 27, 1999. In cooperation with FDA, University of California at Davis also developed a series of videos related to sprout safety (http://postharvest.ucdavis.edu/libraries/video/). These documents are considered guidance and are designed to assist you in complying with the Food, Drug, and Cosmetic Act. If you plan to implement an alternative approach to treating seed and testing spent irrigation water that will provide comparable assurances of detecting and controlling pathogenic bacteria in your sprouts, please provide a copy of your sampling schedule and testing method to the address below.
Please send your reply to the U.S. Food and Drug Administration, Attention: Heidi Marks, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding this letter, please contact Ms. Marks at 425-483-4862 or by email at email@example.com.
Charles M. Breen