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  5. Lee Seed Company Inc - 04/14/2016
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Lee Seed Company Inc

Lee Seed Company Inc

United States

Issuing Office:
Kansas City District Office

United States


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Southwest Region
Kansas City District
8050 Marshall Drive
Suite 205
Lenexa, Kansas 66214-1524


April 14, 2016
Ref. CMS Case: 494246
Scott A. Lee, President
Lee Seed Company Inc.
2242 Hwy 182
Inwood, Iowa 51240­­­­
Dear Mr. Lee:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility located at 2242 Hwy 182, Inwood, Iowa on March 17-22/16. The inspection found significant deviations of FDA’s Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These deviations cause the foods manufactured and stored at 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 they were 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 and its implementing regulations on FDA’s home page www.fda.gov.
Specifically, our inspection of your facility revealed the following CGMP violations:
1.    All reasonable precautions are not taken to ensure that production procedures do not contribute to contamination of finished soybeans from any source, as required by 21 CFR 110.80. Examples include, but are not limited to: manufacturing equipment for processing soybeans (roasters) are not cleaned and emptied properly since at least 2014, uncovered manufacturing equipment located near rodent and insect activity and raw soybeans open to an insanitary surrounding environment. 
2.    Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of soybeans on the premises by pests, as required by 21 CFR 110.35(c). Examples include, but are not limited to: dead mice located near manufacturing equipment where finished product (roasted soybeans) is stored, rodent excreta around (b)(4) boxes of wheat in storage areas, and rodent pellets on shelving units in packaging areas.
3.    Failure to maintain buildings and physical facilities in repair sufficient to prevent soybeans from becoming adulterated, as required by 21 CFR 110.35(a). Examples include, but are not limited to: Storage rooms with outside light entering through the roof and walls, nesting material on cardboard boxes and rodent excreta in finished product soybean storage areas. Similar problems were noted in your packaging room, storage and production rooms as well as on the floors of your facility.
4.    Cleaned and sanitized portable equipment with food-contact surfaces and utensils are not stored in a location and manner that protects food-contact surfaces from contamination to soybeans, as required by 21 CFR 110.35(e). Examples include, but are not limited to: uncovered totes used to mix and store finished product, and utensils left uncovered and located near employee restroom.
5.    Failure to provide adequate lighting in areas where soybeans are examined, stored, or processed, as required by 21 CFR 110.20(b)(5). Examples include, but are not limited to: flashlights were necessary to observe corners in your facility where insanitary conditions exist. Inadequate lighting was noted in you storage areas where you store seasonings and trail mix additives for your soybeans. Lastly, ceiling lights in production areas were not operational.
6.    Failure to provide hand washing facilities at each location in the plant where needed, as required by 21 CFR 110.37(e)(1). There is no hand washing sink in your restroom and employees must walk past soybean production areas to wash their hands. 
7.    Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). Employees were observed not washing their hands in between soybean operations. In addition, gloves used by your employees were found to be worn on the inside which comes into contact with the wearer’s ungloved hands. 
8.    Failure to wear hair nets where appropriate, as required by 21 CFR 110.10(b)(6). Your employees were witnessed performing roasting operations of soybean products and not wearing any sort of hair restraint(s). This is significant because your manufacturing steps entail leaning over finished product (sotbean) for certain periods of time.
9.    Failure to properly identify toxic cleaning compounds in a manner that protects against contamination of food, food-contact surfaces and food-packaging materials, as required by 21 CFR 110.35(b)(2). An unlabeled spray bottle containing liquid was found in your soybean production area. Additionally, lubricants and pressurized cans were observed on a ledge next to where finished soybeans are loaded into the packaging hopper in the packaging room. 
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products, injunction and/or prosecution.
Additionally, we acknowledge receipt of your FDA Form 483, Inspectional Observations, response letter, dated 4/11/16. Your written response does not contain conclusive corrective actions and/or closure date specifics. 
We request that you notify this office in writing, within fifteen (15) working days of receipt of this letter. Your response should include the specific steps you have taken to correct the violations. If you cannot complete all of the corrections within 15 working days, please state the reason for the delay and the time within which corrections will be completed.
Your response should be directed to: Eric Mueller, Compliance Officer, U.S. Food and Drug Administration, Omaha Resident Post, 10918 John Galt Blvd., Omaha, NE 68137. If you have any questions, please do not hesitate to call CO Mueller at: 402-331-8536 ext. 101 or send him an email at eric.mueler@fda.hhs.gov.
Cheryl A. Bigham
District Director
FDA Kansas City District Office

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