- Delivery Method:
Recipient NameJay R. Louie
- Louie Foods International
471 South Teilman Avenue
Fresno, CA 93706
- Issuing Office:
- San Francisco District Office
U.S. Food and Drug Administration
Office of Human and Animal Foods Division West 5
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502
UPS OVERNIGHT DELIVERY
August 21, 2017
Jay R. Louie, President
Louie Foods International
471 South Teilman Avenue
Fresno, California 93706
Dear Mr. Louie:
The Food and Drug Administration (FDA) conducted an inspection of your sprout operation and food processing facility, located at 471 South Teilman Avenue, Fresno, California, from February 13 through February 28, 2017. The inspection revealed that your alfalfa and mung bean 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 the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110) 1. These conditions cause the food products produced at your facility, including your noodles and wonton wrappers, 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 may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your March 21, 2017 response that describes corrective actions you took or will take. However, we are unable to evaluate the adequacy of your response because you did not include documentation, such as records or photos, as evidence of your compliance. We intend to verify the adequacy of your corrective action at a future inspection.
Insanitary Conditions and Practices in the Sprout Operation
Our investigators observed the following conditions and practices at your firm during the processing of sprouts:
1. While an employee was using a high pressure spray hose to rinse trays used for alfalfa sprouts on the floor, water was observed splashing off the floors and trays onto the bottom rack of alfalfa sprouts stored adjacent to the location of spraying. We note that pathogens such as L. monocytogenes that may be present on the floor may contaminate your alfalfa sprouts when aerosol from the floors lands on the product.
2. The bins containing mung bean sprouts were stacked one on top of another so that sprouts were in direct contact with the bottom of another bin. Directly prior to stacking, the bottoms of the bins were observed coming into contact with a black plastic pallet that was soiled with dirty water and old wet mung bean seeds.
3. On multiple occasions, employees were observed mixing and packaging sprouts with unwashed/unsanitized hands. Employees touched insanitary objects such as street pants, control panels with build-up of debris, and a dirty spray hose that was dragging on the floor. The employees then resumed handling sprouts without first washing and sanitizing their hands. We note that it was not possible for the employees to adequately wash their hands in the in the alfalfa sprout production room because the sink was not equipped with soap or paper towels. Soap, or some other surfactant, and adequate drying are essential for the removal of human pathogens from hands.
4. Our investigators observed your two existing toilet facilities available to your employees, where one toilet facility lacked running water in the hand-washing sink, and the other toilet facility lacked a supply of toilet paper. A toilet contained fecal matter. The water from one hand sink was brownish and cold. We note, human feces are a known source of human pathogens and based on the lack of toilet paper in one toilet facility and the general lack of adequate hand washing facilities it is likely that your employees could not adequately wash the feces off their hands after using the toilet.
CGMP Violations in the Processing Facility
During our inspection, FDA investigators observed the following significant violations of the CGMP regulation for your processed food products, including your noodles and wonton wrapper products (21 CFR Part 110):
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). Additionally, your firm failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Our inspection documented the following:
a. Apparent rodent excreta pellets, too numerous to count, were observed on a piece of unused equipment along the North East corner of the old tofu room approximately 5 ft. away from the packaging area for noodles and wonton wrappers separated by an air curtain.
b. Apparent dead insects, too numerous to count, were observed on the floor along the North East corner of the old tofu room adjacent to the packaging area for the noodles and wonton wrappers separated by an air curtain.
2. You did not ensure that food-packaging materials are safe and suitable to comply with the requirements of 21 CFR Part 110. Specifically, a bird dropping was observed on the exterior surface of a folded cardboard box used to store packaged noodles. Three birds were observed flying over the boxes and perched above the noodle packaging.
3. Employees working in direct contact with food and food-contact surfaces did not conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 110.10(b)(6) and 110.10(b)(9). During inspection, our investigators observed:
a. Four employees with mustaches while in direct contact with noodle processing were not wearing facial coverings.
b. An employee was wearing an exposed bandage over a finger while directly handling processed noodles.
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.
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.
In addition, we offer the following comments:
• FDA laboratory analysis of environmental sample number 950546 collected on February 15, 2017, confirmed that two (2) environmental subsample swabs collected from the floor and the drain in your cooler were positive for Listeria monocytogenes (L. monocytogenes) a human pathogen. We recommend that you take steps to monitor and control L. monocytogenes in the environment to prevent it from getting into your finished foods.
• On at least two occasions in your sprout operation, our investigators observed an employee entering the alfalfa sprout de-hulling/packing room without changing or sanitizing his footwear prior to entry. We also note that the foot bath tested below the effective level of 200 ppm QUAT listed on the label. Failure to maintain foot baths and footwear throughout your RTE processing areas, may allow pathogens and other debris to enter the RTE processing areas that could contaminate raw materials and finished food products.
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. More specifically, your response should include documentation of the corrections and/or corrective actions your firm has taken. 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.
Please send your reply to the attention:
Acting Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District, HAF 5W
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference the CMS case # 524457 in your response.
If you have any questions about the content of this letter please contact Juliane Jung-Lau, Compliance Officer, at (510) 337-6793.
Darla R. Bracy
District Director, San Francisco District
Program Division Director, Office of Human & Animal Foods Operations – Division 5 West
1 Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117)(PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates for PC rule compliance dates.