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  5. Jack & The Green Sprouts, Inc. - 697257 - 03/19/2025
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WARNING LETTER

Jack & The Green Sprouts, Inc. MARCS-CMS 697257 —

Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Vincent D. Mahoney
Jack & The Green Sprouts, Inc.

N8477 770th St.
River Falls, WI 54022
United States

Issuing Office:
Human Foods Program

United States

March 19, 2025

WARNING LETTER

CMS #697257

Dear Mr. Mahoney:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at N8477 770th St., River Falls, WI 54022 on October 9, 2024, through October 21, 2024. Based on inspectional findings collected during the inspection, we have identified significant violations of Title 21, Code of Federal Regulations Part 112, Standard for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Packing (Produce Safety Rule) that cause your sprouts to be adulterated within the meaning of 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Failure to comply with the Produce Safety regulation is a prohibited act under section 301(vv) of the Act [21 U.S.C. § 331(vv)]. Further, based on analytical results for your sprouts collected on September 23, 2024, October 1, 2024, and January 27, 2025, we have also determined that your sprouts are adulterated within the meaning of Section 402(a)(1) of the Act [21 U.S.C. § 342(a)(1)] in that your sprouts bear or contain any poisonous or deleterious substance which may render it injurious to health. You can find the Act and FDA regulations and the applicable regulations through links on FDA's home page at www.fda.gov.

At the conclusion of the inspection on October 21, 2024, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). To date, we have not received a response addressing the FDA 483.

Pathogen Findings

Listeria monocytogenes (L. monocytogenes) is a pathogenic bacterium that is widespread in the environment and may be introduced into a sprouting operation from raw materials, humans, or equipment. Without proper sanitation practices, it can proliferate in a sprouting operation where it may contaminate food. Consuming food contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, a foodborne illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions.

The Minnesota Department of Agriculture (MDA) collected two samples of your sprouts on September 23, 2024 as part of the FDA/State Laboratory Flexible Funding Model (LFFM) sampling program. These samples tested positive for L. monocytogenes. In response to the findings in your sprouts, you recalled alfalfa lots (b)(4) and (b)(4). In addition, you collected finished product samples in October 1, 2024 that tested positive for L. monocytogenes. In response to the findings in your sprouts, you recalled alfalfa sprouts lots (b)(4) and (b)(4), and alfalfa and onion sprouts lot (b)(4). On January 27, 2025, MDA collected, as part of the LFFM sampling program, a sample of alfalfa sprouts, which tested positive for L. monocytogenes. On February 7, 2025, you initiated a recall of lot (b)(4) of alfalfa sprouts.

Produce Safety Rule Violation
During the inspection, FDA investigators observed the following significant violation of the Produce Safety regulation, 21 CFR Part 112:

1. Your written environmental monitoring plan does not include a sampling plan that specifies a sufficient number of sampling sites to determine whether measures are effective as required by 21 CFR 112.145(c)(3).

Your sprout production area is (b)(4) sq. ft. and you are in production Monday through Friday from (b)(4)am to typically around (b)(4)pm. Your environmental monitoring plan entitled, “Environmental Monitoring/Testing” states that you take (b)(4) environmental monitoring swabs each month, ranging between zones (b)(4). Your environmental monitoring plan also states that its objectives include testing for the presence of Listeria spp. within the production environment and tracking the monitoring data to identify Listeria contamination trends in the production environment.

Your environmental monitoring plan does not contain sufficient sampling sites to determine whether your Listeria species or L. monocytogenes measures are effective, in that you are not able to determine whether Listeria species or L. monocytogenes is present in the production environment. From July 26, 2024 to September 30, 2024, you did not obtain any positive sampling results when following your sampling plan. However, MDA collected product samples within that time period which tested positive for L. monocytogenes. Further, on October 1, 2024 when you sampled your products in response to the MDA findings of L. monocytogenes in your facility, you obtained multiple positive findings. Finally, when you did increase environmental sample numbers, you found Listeria spp. on food contact and non-food contact surfaces. Specifically, on October 6, 2024 and October 9, 2024, you received notification from your contract laboratory that environmental samples collected on October 5, 2024 and October 7, 2024 respectively, yielded Listeria species. These findings indicate that the sampling sites specified by your environmental monitoring plan were not sufficient to detect the presence of Listeria or L. monocytogenes, in that you did not detect Listeria or L. monocytogenes when following your sampling plan and when they were in fact present in both your environment and in your sprouts.

The violations cited in this letter are not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

In addition, we have the following comments:

During the most recent inspection during a time when you were not in operation, our investigators noted that your food contact surfaces were not clean and sanitary. We further note that the environmental samples that you collected that yielded Listeria species were collected after you believed you had cleaned. You must use equipment and tools that are of adequate design, construction, and workmanship to enable them to be adequately cleaned, as required by 21 CFR 112.123(a).

In addition, we observed significant rodent activity during our inspection. Specifically, we observed apparent rodent excreta pellets throughout the blue shed, including on pallets of seed, in cardboard boxes containing equipment or packaging materials, and on equipment (hand-held metal sieves). The blue shed is also connected to Building A, where you conduct sprouts production. Further, we observed apparent rodent excreta pellets on pallets of packaging material (cardboard cases) in Building (b)(4). We also observed apparent rodent excreta pellets caught in shrink wrap enclosing pallets of packaging material (cardboard cases). Fur and a small skull were observed on the floor between two rows of pallets. Additionally, we observed gnaw holes, staining, chewed material, and apparent rodent excreta pellets on three bags of garbanzo beans. Chewed material and apparent rodent excreta pellets were also on pallets and bags of green peas, lentils, and adzuki beans/seeds. You must take measures reasonably necessary to protect covered produce, food contact surfaces, and food-packing materials from contamination by pests in buildings, as required by 21 CFR 112.128(a). You must also take measures to exclude pests from fully-enclosed buildings, as required by 21 CFR 112.128(b).

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written reply should be directed to Rochelle Blair via email at HFP-OCE-Produce@fda.hhs.gov. If you have any questions, you may email at HFP-OCE-Produce@fda.hhs.gov.

Sincerely,
/S/

Laura Akowuah, JD, MPH
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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