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WARNING LETTER

Everything Sprouts, LLC MARCS-CMS 699480 —

Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Melissa L. Mann
Recipient Title
Owner
Everything Sprouts, LLC

2751 Minnehaha Ave.
Minneapolis, MN 55406-1546
United States

Issuing Office:
Human Foods Program

United States

March 28, 2025

WARNING LETTER

Dear Ms. Mann:

The U.S. Food and Drug Administration (FDA) inspected your sprouting operation, located at 2751 Minnehaha Ave., Minneapolis, MN 55406-1546 on October 30, 2024, through November 14, 2024. The inspection revealed serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation (Produce Safety Regulation or PSR), Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112).

Based on our inspectional findings, we have determined that your mung bean, soybean, and green sprout products are 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 have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath. In addition, failure to comply with the PSR is a prohibited act under section 301(vv) of the Act [21 U.S.C. § 331(vv)]. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.

At the conclusion of the inspection on November 14, 2024, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We received your written responses dated December 5, 2024, and December 6, 2024, which describe your completed and planned corrective actions to the Form FDA 483. We address your responses below.

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

1. You did not implement measures to prevent contamination of your covered produce and food contact surfaces through walls, ceilings, fixtures, ducts, pipes, drip, and condensate, as required by 21 CFR 112.126(b).

Specifically, on October 31, 2024, our investigator observed the roof leaking through the ceiling tiles in the middle of the production room approximately four feet from the packaging tables. Water from the leak was observed dripping onto the totes of cooled, exposed mung bean sprouts as pallets were transferred through the area for packaging. On November 4, 2024, our investigator observed a roof leak in the warehouse, with water dripping near a rack of clean smocks prepared to be worn by employees directly in contact with covered produce. In addition, our investigator observed condensate dripping from the condenser units inside the in-process and finished product coolers storing mung bean sprouts, as well as dripping onto the door frame and into the finished product cooler.

We acknowledge your responses dated December 5, 2024, and December 6, 2024, detailing your corrective actions; however, we are unable to evaluate the adequacy of your corrective actions. Your response stated your firm’s intent to create a standard operating procedure (SOP) to respond to leaks, including specific procedures such as blocking off the affected area or utilizing drain tarps to mitigate contamination. Additionally, your response stated that you will address dripping condensate through daily inspections and the use of a squeegee, with long-term plans to install drip pans or replace the condensing units. During previous FDA inspections of your sprout operation conducted in 2023 and in 2018, while your sprout operation was under different ownership but still operating within the same facility, our investigators observed dripping condenser units. You have not included, as a part of your response, any information that addresses how you will prevent the contamination by preventing the source of the leak, such as addressing the disrepair of the roof. You indicated to our investigator that you rent this building and that your landlord would repair the roof as a long-term project. However, you did not provide an estimated date of repair. As a covered farm, you must ensure compliance with applicable provisions of the Produce Safety Rule, including implementing measures necessary to prevent contamination of covered produce and food contact surfaces as required by 21 CFR 112.126(b). We will evaluate the adequacy of your corrective actions at our next inspection.

2. You did not clean and sanitize food contact surfaces that you use to grow, harvest, pack, or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts, as required by 21 CFR 112.143(b).

“Food contact surfaces” are defined as those surfaces that contact human food and those surfaces from which drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. “Food contact surfaces” includes food contact surfaces of equipment and tools used during harvest, packing, and holding. (See 21 CFR 112.3).

During the inspection, our investigator observed dripping condensate on the underside of the water supply apparatus on the overhead irrigation system and rails, which passes directly over exposed mung bean sprouts in the growing cabins. Additionally, our investigator observed a build-up of black organic matter on the hose of the overhead irrigation system used for soy sprouts, which passed directly over exposed soy sprouts. Our investigator also observed white build-up on the interior surface of black plastic sheets enclosing soy sprout growing cabins, which was ripped in several places. Our investigator noted attempts to improperly repair these concerns with tape, with sprouts adhered to tape in multiple locations throughout the facility. 

We acknowledge your responses dated December 5, 2024, and December 6, 2024; however, we are unable to evaluate the adequacy of the corrective actions detailed in your responses. Specifically, your response indicates that condensate will be squeegeed, repairs and alternate methods of plugging gaps will be made, and that the black plastic sheeting will be changed out as needed. However, we note that fully addressing the sources of damage to your facility may be required to avoid contamination of covered produce, as incomplete repairs to gaps and other structural deficiencies within food contact surfaces may create harborage points for pathogens and make it increasingly difficult to properly sanitize the surface. We will evaluate the adequacy of your corrective actions at our next inspection.

This letter is not intended to be an all-inclusive statement of violations that may exist 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 with an opportunity to address them. Failure to adequately address this matter may result in legal action by the FDA without further notice, including, without limitation, seizure and/or injunction

We also offer the following comment:

  • During the inspection, our investigator observed that visibly soiled strip curtains separating the mung bean growing and production rooms came in direct contact with harvested mung bean sprouts as they moved between rooms for washing. In addition, the investigator noted flaking paint and visible soil on the motor house and cinderbrick walls in the pass-through area between the mung bean growing and production rooms, which is located directly above the conveyor belt that transfers exposed, harvested mung bean sprouts. We acknowledge your responses dated December 5, 2024, and December 6, 2024, in which you state that you will clean your plastic strip curtains. However, your responses did not provide supporting evidence for us to assess your corrections to the strip curtains or address the disrepair of the surfaces around the conveyor belt. As a reminder, it is your responsibility to inspect, maintain, and clean, and when necessary and appropriate, sanitize all food contact surfaces of equipment and tools used in covered activities as frequently as reasonably necessary to protect against the contamination of covered produce, as required by 21 CFR 112.123(d)(1).

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that 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 action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

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