|Company:||Sun Hang Bean Sprout Inc|
|Subject:||CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions|
|Issuer:||Detroit District Office|
|Issued:||Jan. 19, 2010||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
January 19, 2010
VIA FEDERAL EXPRESS
Rui Cai Li, President
Sun Hang Bean Sprout, Inc.
1330 Erskine Street
Detroit, Michigan 48207
Dear Mr. Li:
We inspected your bean sprout processing facility, located at 1330 Erskine Street, Detroit, MI on September 25-0ctober 16, 2009. Our investigators documented significant observations of insanitary conditions. Moreover, an analysis of environmental swabs collected at your facility found the pathogen Listeria monocytogenes (
). Both the conditions observed by our inspectors and the finding of
cause the mung bean sprouts processed at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(4)], in that your sprouts 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.
The following conditions were noted during the inspection of your facility:
1. During at least six different instances, our investigators observed employeesdragging perforated barrels containing bean sprouts along the wet cement floor. The floor was observed with up to one inch of flowing water which contacted open sewage drains as well as the perforated barrels containing bean sprouts. None of the perforated barrels were washed or sanitized after direct contact with the wet floor, between process steps, or after periods of non-use. Dragging perforated barrels of exposed bean sprouts through floor water could contaminate the sprouts with harmful bacteria.
2. An employee was observed standing in water directly in front of, and within six inches of the wooden pallet-mounted centrifuge, and then subsequently using the bottom of his boot to slow and stop the perforated barrel of ready-to-pack bean sprouts from spinning inside the centrifuge. The wooden pallet was visibly soiled and bolted to the cement floor. Using a soiled shoe to slow the perforated centrifuge barrel containing bean sprouts could contaminate the sprouts with harmful bacteria.
3. When filled with bean sprouts the perforated barrels are stagger-stacked twoperforated barrels deep so that the bottom holes of one perforated barrel are directly over the bean sprouts in the perforated barrel below it. These barrels are routinely transported directly on the wet cement floor in the wet processing area. By stacking the perforated barrels that have been dragged on the floor, you cross-contaminate the product-contact surface of one barrel with the soiled surface of another barrel. This practice could contaminate the bean sprouts with harmful bacteria.
4. More than 100 apparent rodent excreta pellets were observed in your facility. There also appeared to be rodent nesting in the 3-inch-diameter hole in the wall/floor junction of the restroom. Rodents can contaminate food and food contact surfaces with harmful bacteria and filth.
5. An insect appearing to be a German cockroach was observed crawling on the wall approximately one foot away from, and above, the separating machine (the sprout rinse tank). Apparent cockroaches were also observed on, around, and underneath the wooden pallet-mounted centrifuge. Insects, such as cockroaches, can contaminate food and food-contact surfaces with harmful bacteria and filth.
6. The white plastic shovels used to transfer bean sprouts in the wet processing room were observed to have brownish-black build-up on their food contact surfaces and around the portion of the shovel directly above the blade that was used as a grip. The failure to properly clean food-contact surfaces such as these shovels could lead to the contamination of food with harmful bacteria.
7. A yellowish-orange plaque build-up was observed on the separating machine (the sprout rinse tank) and the flume at the end of the machine. We also observed a brownish-black residue around the separator conveyor chain, bearing housing, and around the projections that rotate and separate sprouts. The failure to properly clean food-contact surfaces such as these could lead to the contamination of food with harmful bacteria.
8. At no time during the inspection were any employees observed washing or sanitizing hands. Employee hands were observed coming into direct contact with bean sprouts during the following processing steps: loading of fully grown sprouts into perforated barrels, handling of sprouts in the separation tank, collection of bean sprouts from separation tank into perforated barrels, and packing of rinsed and centrifuged bean sprouts into 25 lb. capacity plastic bags. Moreover, the employee stationed between the separation tank and the centrifuge was observed touching rinsed sprouts exiting the flume and falling into a perforated barrel immediately after he carried a full bucket to the centrifuge and pushed a soiled button on the centrifuge control panel, without first washing and sanitizing his hands. The failure to wash and sanitize hands prior to handling the bean sprouts could lead to the contamination of the sprouts with harmful bacteria.
9. On at least six different instances our investigators observed condensation dripping directly onto already rinsed and centrifuged bean sprouts, as well as finished sprouts stored in perforated bags. These sprouts were stored in your West and East refrigerators. In addition, sprouts in perforated barrels were also observed being stored in standing water in your East refrigerator. Storing perforated barrels of sprouts in standing water can lead to the contamination of the sprouts with harmful bacteria, as can storing sprouts under dripping condensation.
During the inspection the FDA investigators collected sample number 519223 consisting of 41 environmental swabs. The results of the analysis of these environmental swabs found the pathogen
in your facility, on a pallet under the sprout centrifuge machine.
is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility.
can contaminate foods, resulting in a mild illness (called listerial gastroenteritis) or a severe, sometimes life-threatening, illness called invasive listeriosis. Immune-compromised individuals and unborn fetuses are particularly susceptible to Listeriosis. In the past, sprouts that are ready-to-eat (RTE) have been implicated in outbreaks of invasive listeriosis.
can be isolated from soil, silage and other environmental sources and can also be found in man-made environments such as food processing establishments. Any moist area, such as your sprout production area, can harbor
. This organism can grow at refrigeration temperatures. During our inspection, we documented conditions and practices that may lead to the contamination of your products with pathogens such as
and may be conducive to pathogen growth in your products.
You may find the Act through links in FDA's home page at www.fda.gov. In addition, you may wish to reference the FDA guidance document entitled "Guidance for Industry: Reducing Microbial Food Safety Hazards For Sprouted Seeds," which is available at http://www.fda.gov/Food/GuidanceComplianceRegulatorylnformation/GuidanceDocuments/ProduceandPlanProducts/ucm120244.htm
We acknowledge the verbal commitment you made during the inspection that you would clean your facility, create and maintain a cleaning schedule, and provide education to your employees concerning hygiene and proper food handling. These efforts will be verified at our next inspection.
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and applicable regulations. 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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your written reply to the Food and Drug Administration, Attention: Catherine V. Quinlan, Compliance Officer, 300 River Place, Suite 5900, Detroit, Michigan, 48207. If you have any questions regarding any issues in this letter, please contact Ms. Quinlan at (313) 393-8153.
Joann M. Givens
Detroit Dlstrict Office