Inspections, Compliance, Enforcement, and Criminal Investigations
Lucky Farm Inc 2/18/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
February 18, 2010
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-14
Kien D. Tran, President and Owner
Lucky Farm, Inc.
6849 Northeast Columbia Boulevard
Portland, Oregon 97218-3348
Dear Mr. Tran:
We inspected your bean sprout processing facility located at 6849 Northeast Columbia Boulevard, Portland, Oregon, on September 22, 23, 28, 30, and October 2, 2009. Our investigators documented significant insanitary conditions. These conditions cause the products manufactured, processed, and stored in your facility to be 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 your bean sprouts have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health.
We observed the following conditions during the inspection of your facility:
1. Our investigators observed rodents, rodent excreta, and insects in your facility. Specifically
- On September 28, 2009, one live rodent, brown, with a body approximately four inches long, was on a glue trap in the northwest corner of your processing room on top of a drain in a 1.5 inch gap under the wall between the processing room and the growing room.
- On September 28, 2009, one live rodent, brown, with a body approximately three inches long, was on a glue trap in the warehouse behind the open north door of the processing room approximately one foot from the floor drain which runs between the warehouse, the processing room and the adjoining firm in the same building.
- On September 30,2009, one live rodent, brown, with a body approximately three inches long, was taken out of your facility through the south door and brought to a dumpster by the General Manager.
- On September 28 and 30, 2009, rodent excreta pellets were on the floor along the north wall of the growing room approximately 20 feet from a live rodent, ten feet from the floor drain, and five feet from open bins of germinating mung bean sprouts.
- On September 28, 2009, rodent excreta pellets were on a wooden pallet on the second shelf in the southwest area of your warehouse (b)(4) 55 pound bags of mung bean seeds were stacked on this pallet. Rodent excreta pellets were found between the bottom layer of bags within one fourth inch of the bags. Rodent excreta pellets were found directly under one bag of mung bean seeds on the bottom layer of bags.
- On September 22, 23 and 28, 2009, at least two live flies were flying around inside your processing room during processing and packaging of mung bean sprouts.
- On September 28, 2009, flying insects, subsequently identified as fungus gnats, too numerous to count were flying throughout the sprout processing room and sprout growing room, swarming within an inch of the floor drain in the processing room and growing room, and swarming underneath the sinks in the processing room during processing and packaging of mung bean sprouts.
Rodents and insects can contaminate food and food-contact surfaces with harmful bacteria and filth.
2. Our inspectors observed employees touching unclean nonfood-contact surfaces during processing of ready to eat mung bean sprouts, and then handling inprocess ready to eat mung bean sprouts without first washing and sanitizing their hands. Specifically:
- On September 22, 2009, the owner picked up a rodent trap from the floor along the south wall of the growing room. A few minutes later, he took a handful of sprouts out of a growing bin with his hand without first washing his hands.
- On September 22, 2009, an employee with gloved hands entered the processing room touching the rusty metal door on the west wall of the processing room during processing of mung bean sprouts. He then dipped his gloved hands into the bean sprout wash tank touching ready to eat mung bean sprouts without first washing his gloves.
- On September 22, 2009, an employee with gloved hands touched the handle of the Walk in cooler and a rusty metal cart. He then packaged ready to eat mung bean sprouts into five pound bags with the same gloves.
- On September 22 and 28, 2009, an employee touched with his gloved hands a rusty metal stepping stool, on which he had been stepping, and the outer sides of a sprout growing bin. He then moved mung bean sprouts from the bin into the washing tank using the same gloves. The same employee then touched a rusty lever to adjust the water in the tank. He then reached into the washing tank and touched the mung bean sprouts during processing using the same gloves.
- On September 22 and 23, 2009, an employee packaged ready to eat mung bean sprouts into plastic bags using gloves which had a hole in the thumb without first washing his hands.
- On September 23, 2009, a fly landed on an employee's gloved hand while he was cleaning a bin used for growing sprouts. He continued to clean the bin without changing his gloves.
- On September 23, 2009, two employees touched the plastic curtains between the processing room and the warehouse/office area with their gloved hands four times while processing mung bean sprouts using the same gloves.
The failure of your employees to wash and sanitize their hands prior to handling bean sprouts could lead to the contamination of the sprouts with harmful bacteria.
3. On September 28 and 30, 2009, our investigators observed bean sprout residue and black and brown residue inside the bean sprout wash tank after the equipment was cleaned and prior to the processing of mung bean sprouts. The conveyor belt used to move bean sprouts from the wash tank to the holding tank had dots of black residue throughout the food-contact surface side of the belt as well as on the underside of the belt. There was black residue on the welded metal seams on the inside of the tank used to hold washed, dried, ready to eat bean sprouts prior to packaging, both after the washing tank was cleaned and before bean sprouts were processed. The white buckets used to spin dry the sprouts had approximately one fourth inch holes cut in them throughout the sides of the buckets. These holes had rough edges, and there was brown residue on these edges prior to and during processing of mung bean sprouts each day of the inspection. These failures to adequately clean food-contact surfaces can lead to the contamination of food with harmful bacteria.
4. An employee was observed spraying pressurized water onto your processing room floor, which was pitted and covered with a slimy black residue throughout the room. The pressurized water spray splashed up from the floor, contacting the sprout washing equipment, during the washing and packaging of mung bean sprouts on September 23 and 28, 2009. This practice can lead to the contamination of bean sprouts with harmful bacteria.
5. There is a one inch gap in the west wall, near the floor, around a sink drain pipe where it exits the processing room into an adjacent business. During the inspection you told one of our investigators that you have seen a mouse squeeze through this hole and enter into the processing room. When closed, the loading dock door on the east side of your facility has an approximately one inch gap to the outside at the lower north corner. The south door leading to the outside also has an approximately one inch gap under the door at the lower east corner when closed. Moreover, there is an approximately three inch diameter hole in the south wall approximately nine feet above the floor leading to the outside. These conditions do not protect against pests entering your facility, which can lead to the contamination of bean sprouts with harmful bacteria.
We acknowledge the verbal commitment you made during the inspection to clean up pest activity, block holes in the facility walls, clean and repair the bean sprout holding and wash tanks, obtain a new conveyor belt, clean the processing room floor and spinner buckets, and provide additional employee training regarding handwashing and other protections against food contamination, including cleaning of the equipment and facility. These efforts will be verified at our next inspection.
You can 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/GuidanceComplianceRegulatorvlnformation/GuidanceDocu
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility and your products are 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: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen
Copy of FDA 483
cc: ODA, with disclosure statement