WARNING LETTER

Schlechter Farms Inc. MARCS-CMS 722153 — March 18, 2026

Product:: Food & Beverages

Recipient:: Recipient Name

James J. Schlechter; Recipient Title

Owner; Schlechter Farms Inc.; 10143 86th Ave NE
Salem, OR 97305
United States

Issuing Office:: Human Foods Program; United States

WARNING LETTER
CMS # 722153

March 18, 2026

Dear Mr. Schlechter:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your farm located at 10143 86th Ave NE, Salem, Oregon, from December 16, 2025, through December 19, 2025. Our inspection revealed serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety regulation), Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112). Based on FDA’s inspectional findings, we have determined that your onions are 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)], 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 health. In addition, 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)]. You can find the Act and FDA’s regulations through links on FDA's home page at www.fda.gov.

At the conclusion of the inspection on December 19, 2025, our investigator provided you with a Form FDA 4056 (FDA 4056), Produce Farm Inspectional Observations, listing the observations at your farm during our inspection. To date, we have not received from you a written response addressing the FDA 4056.

The significant violations of the Produce Safety regulation are as follows:

1. You did not take measures to exclude pests from your fully enclosed building, as required by 21 CFR 112.128(b).

Specifically, on December 16 and 18, 2025, during inspection at your farm, FDA investigators observed bird feces, too numerous to count, throughout your onion packing shed, including on the wooden rafters directly above the packing line and on (b)(4) box fans mounted in the walls on the (b)(4) side of the onion packing shed. These box fans lacked protective coverings, allowing for pest (e.g., bird) entry when the fans are not operating.

In addition, on December 16 and 18, 2025, (b)(4) bird nests were observed in your packing shed, and you indicated this is recurring nesting activity which occurs annually during spring. You also explained that when onion packing operations conclude, the onion packing shed is used for equipment storage throughout the remainder of the year. During these times, you stated (b)(4). We note that 21 CFR 112.128(b) requires measures to exclude pests from fully enclosed buildings.

During the inspection, you stated (b)(4). We will evaluate the adequacy of your corrective actions at the next inspection.

2. You did not take measures that were reasonably necessary to protect covered produce, food contact surfaces, and food-packing materials from contamination by pests in your building, as required by 21 CFR 112.128(a).

Specifically, on December 16, 2025, during an inspection at your farm, FDA investigators observed accumulated bird feces on (1) grating on the in-line top-tailer machine, directly above where onions were being topped and de-rooted; (2) a light fixture directly over two packing lines where onions were being sorted; and (3) a hand rail on the (b)(4) wall used by employees walking on stairs and elevated platforms along the packing line.

During the inspection, you stated (b)(4). We will evaluate the adequacy of your corrective actions at the next inspection.

An FDA investigator discussed similar issues with you during the inspection that occurred on December 13 through December 15, 2023. This was also discussed with you during a regulatory meeting held on April 3, 2024.

3. You did not inspect, maintain, and clean and, when necessary and appropriate, sanitize 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).

Specifically, on December 16, 2025, during an inspection at your farm, FDA investigators observed numerous bird feces on food contact surfaces, including two conveyor belts on your onion pallet line and the (b)(4) onion bagging line elevator conveyor. Onions were observed contacting these areas while being packed. You stated (b)(4).

On December 17 and 18, 2025, you stated (b)(4). When you instruct employees to clean, they dip wash cloths into buckets of well water with hand soap added and use them to clean areas of the line that appear dirty. Afterwards, Briotech (a sanitizer) is dispensed by hand spray bottles and applied to the surfaces of the packing lines as determined necessary by employees. Your statements indicated that this is an ad hoc, employee-judgment-based approach to cleaning and sanitizing. You acknowledged that while using this cleaning process on December 12, 2025, your employees missed the bird feces our investigators subsequently observed on December 16, 2025.

During the inspection, you stated (b)(4). We note that bird droppings are a known source of human pathogens such as Salmonella. Thus, we remind you that your cleaning and sanitizing must be conducted as frequently as reasonably necessary to protect against the contamination of covered produce, as required by 21 CFR 112.123(d)(1). We will evaluate the adequacy of your corrective actions at the next inspection.

An FDA investigator made a similar observation during the inspection that occurred on December 13 through December 15, 2023. This was also discussed with you during a regulatory meeting held on April 3, 2024.

4. You did not use equipment and tools that are of adequate design, construction, and workmanship to enable them to be adequately cleaned and properly maintained, as required by 21 CFR 112.123(a).

Specifically, on December 16, 2025, despite implementation of the cleaning process detailed in (3) above and the maintenance check your employees conducted of the onion packing line in November 2025, FDA investigators observed soiled carpeting being used on your (b)(4) onion bagging line and making direct contact with onions as they moved through the line. Additionally, FDA investigators observed onions making contact with (1) fraying duct tape on a pole at the end of the palleting line, and (2) frayed, knotted bundles of braided rope on your (b)(4) packing line.

During the inspection, you stated (b)(4). We will evaluate the adequacy of your corrective actions at the next inspection.

5. You did not employ at least one supervisor or responsible party that has successfully completed food safety training at least equivalent to that received under standardized curriculum recognized as adequate by FDA, as required by 21 CFR 112.22(c).

Specifically, on December 17, 2025, you confirmed (b)(4). You currently grow, harvest, pack, and hold the following ready-to-eat produce: onions, tomatoes, cucumbers, zucchini, pole beans, hot peppers, sweet peppers, watermelons, cantaloupes, and cauliflower.

During the inspection, you stated (b)(4). We will evaluate the adequacy of your corrective actions at the next inspection.

An FDA investigator discussed this issue with you during the inspection that occurred on December 13 through December 15, 2023. This was also discussed with you during a regulatory meeting held on April 3, 2024.

6. You did not establish and keep documentation of the date and method of cleaning and sanitizing of equipment used in covered harvesting, packing, or holding activities, as required by 21 CFR 112.140(b).

Specifically, on December 16 and 17, 2025, you confirmed records have not been established and maintained to document the cleaning and sanitizing of food contact surfaces for equipment used in the harvesting and packing of ready-to-eat onions, including your onion packing line, “(b)(4) Machine,” onion harvester machine, 3 dump trailer trucks used for onion transport, and your “(b)(4) Equipment” used to transfer onions from the dump trailers to wooden bins for storage.

During the inspection, you stated (b)(4). You also stated (b)(4). We will evaluate the adequacy of your corrective actions at the 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 an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

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 response should be sent to Joel Merriman, Compliance Officer, at joel.merriman@fda.hhs.gov.

Sincerely,
/S/

Maria S. Knirk, JD, MBA
Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program