Inspections, Compliance, Enforcement, and Criminal Investigations
Alfred Louie Inc 2/21/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone (510) 337-6700
February 21, 2013
UNITED PARCEL SERVICE
Mr. Gordon Louie
Mr. Victor Louie
Alfred Louie, Inc.
4501 Shepard Street
Bakersfield, California 93313
Dear Mr. Louie:
The Food and Drug Administration (FDA) conducted an inspection of your food processing facility, located at 4501 Shepard Street, Bakersfield, California, from September 19 through October 10, 2012. The inspection revealed that your mung bean and soybean sprouts are adulterated within the meaning of section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug and Cosmetic Act (the Act) in that they 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. In addition, the inspection revealed serious violations of FDA’s Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These conditions cause the food products produced and stored at your facility, including the refrigerated noodles, cashews, rice, oolong and jasmine tea, paprika, pepper, and cooked frozen ducks to also be adulterated within the meaning of section 402(a)(4) of the Act in that they have also been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health. You can find the Act and its implementing regulations at www.fda.gov.
Insanitary Conditions and Practices
Our investigators observed the following conditions and practices at your firm during the processing of sprouts:
1. An employee was eating and packing sprouts with bare hands; and employees were packing sprouts with unwashed/unsanitized hands after returning from the restroom, a lunch break or operating a forklift. In addition, there is no hand-washing facility in the sprout production room. Human pathogens such as Salmonella, Hepatitis A, and Shigella spp. may be transmitted to foods by unwashed hands.
2. An employee used the bottom of his rubber boots to turn a wheel on which the packing cylinders rest before coming into contact with the sprouts. The boots were not sanitized. Outer garments such as smocks, aprons, and boots, could become contaminated with pathogens if they are not properly cleaned and sanitized.
3. There were organic and sprout residues on packing cylinders, food contact surfaces of the packing machine, and the belt conveyor after you had completed your clean-up process. You did not conduct cleaning procedures before your next processing/packaging operation. Harmful microorganisms may remain viable on improperly cleaned and sanitized food contact surfaces, equipment, and utensils and these items may lead contamination of the food with which they come in contact.
4. There was standing water and organic matter on the sprout production floor, which was also pitted. These conditions allow for the entrapment of filth and pathogens, and any filth or pathogens present could contaminate the sprouts that are manufactured and stored in the facility.
5. An electrical cord hanging above the de-hulling machine was wrapped in a plastic bag. The plastic bag was filled with brown colored liquid and the bag came into direct contact with in-process sprouts.
6. Open bags of freshly packed bags of mung bean sprouts were stored in reused, unclean, and unsanitized wooden crates. The crates were stacked four high, exposing the bottom three crates of open bags of mung bean sprouts to the bottom of the unclean crate above.
1. You failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c) as evidenced by the following:
- Rodent gnaw holes through cardboard boxes of cashews and various teas, which penetrated into the plastic bags of product within. We acknowledge that you voluntarily destroyed the rodent gnawed cashews and teas.
- Rodent excreta pellets in various areas of your facility, including the sprout production/packing room directly on bags of untreated Mung bean seeds, in the warehouse on dividers of pallets for rice, and along the wall of the freezer.
- A dead mouse at the northeast corner of the food storage warehouse and where the sprout waste containers were stored.
- Live flies flying throughout the sprout production/packing room and warehouse landing on production equipment, food contact surfaces, and non-food contact surfaces.
In addition, you failed to use insecticides or rodenticides under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food packaging materials. Specifically, rodent bait boxes were observed in your noodle room and at various locations of your food storage warehouse with exposed food contact surfaces. In addition, containers of rodent poison were placed in your noodle room and throughout the food storage warehouse. The label states: “Keep away from food and water and surfaces which come in contact with food and water”.
2. You failed to provide, where necessary, adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Specifically, during our inspection, the roll-up exterior doors of your food storage warehouse were left open, and therefore exposed the facility to the outside grounds and allowed for the entry of rodents and other pests.
3. Your plant and facilities failed to provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food as required by 21 CFR 110.20(b)(1). Specifically, your warehouse, walk-in refrigerator, and walk-in freezer have no aisles along the walls to inspect for pests, set traps and clean. In addition, when items were removed from these respective walls, we observed rodent excreta pellets.
4. Your facility is not constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and in good repair and that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.20(b)(4) as evidenced by the following:
- Condensate was observed falling from the overhead forced air cooler unit onto exposed produce being stored for distribution. Uncooked noodles, opened bags of sprouts, tofu and eggs are also stored in this cooler.
- Rust and debris was observed on the pipes directly over sprout growing bins in sprout growing room #2.
5. You failed to ensure that the grounds around the facility are kept in a condition that will protect against the contamination of food as required by 21 CFR 110.20(a). Specifically, our investigator observed equipment, such as a car, motors, equipment parts, a ladder, chairs, etc., piled in disarray around the west and south outside perimeter and southwest entry of your property. These conditions provide a breeding ground for rodents.
We acknowledge your October 21, 2012 response that describes corrective actions taken in response to some of these CGMP deficiencies; however, your response is inadequate as you provided no documentation such as records, invoices, or photos as evidence of your compliance. Therefore, we will verify the effectiveness of your corrective during our next inspection.
In addition, your firm grows and packs soybean sprouts using the same growing and packing equipment as the mung bean sprouts. Your response indicates that you will pack soybean sprouts after the mung bean sprouts. You should also ensure that the equipment has been sufficiently cleaned/sanitized to remove soybean residues after packaging and prior to packaging other foods on the same equipment.
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.
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/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/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/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/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 respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and prevent their recurrence. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.
Your written response should be directed to:
Lawton W. Lum
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94502
Refer to the Unique Identification Number (CMS 382699) when replying.
If you have any questions about the content of this letter please contact Ms. Aleta T. Flores, Compliance Officer at (510) 337-6821.
Barbara J. Cassens