WARNING LETTER

Naumes, Inc. MARCS-CMS 719653 — January 21, 2026

Delivery Method:: Via Email
Product:: Food & Beverages

Recipient:: Recipient Name

Laura E. Naumes; Recipient Title

Owner/Operator; Naumes, Inc.; PO Box 996
Medford, OR 97501-0071
United States

Issuing Office:: Human Foods Program; United States

January 21, 2026

WARNING LETTER

CMS # 719653

Dear Ms. Laura E. Naumes:

The U.S. Food and Drug Administration (FDA) inspected your farm located at 2 W. Barnett Rd., Medford, OR 97501-3666 on September 15, 2025, through September 22, 2025. Our inspection revealed serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation (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 pears 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 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 http://www.fda.gov.

The inspection resulted in FDA’s issuance of a Form FDA 4056 (FDA 4056), Produce Farm Inspectional Observations, listing the observations at your farm during our inspection. We received your written responses dated October 1, 2025, October 21, 2025, and November 13, 2025, which describe your completed and planned corrective actions to the FDA 4056. We address your responses below.

During the inspection, FDA investigators observed the following:

1. You did not manage water used during harvesting, packing, or holding covered produce as necessary to maintain its safe and adequate sanitary quality, as required by 21 CFR 112.44(d)(1).

On September 15, 2025, our investigator observed wooden pear harvest bins being submerged in recirculated, municipal water in dump tanks. The investigator observed several harvest bins to have grass and vegetative debris stuck to the bottom causing the surface of each dump tank to have vegetative debris floating on top. Your farm stated that (b)(4)

(b)(4)

This is a repeat observation from the inspection conducted September 11, 2023 through September 18, 2023.

We acknowledge your response dated November 13, 2025, detailing your corrective actions; however, we are unable to evaluate the adequacy of your corrective actions. Your response stated that your (b)(4). We note that consistent change schedules and clear thresholds for when actions must be taken if vegetative debris accumulates may be helpful in preventing the agricultural water from serving as both a source and route of contamination. We will evaluate the adequacy of your corrective actions during our next inspection.

2. You did not handle harvested produce in a manner that protects against contamination with known or reasonably foreseeable hazards, as required by 21 CFR 112.113.

On September 15, 2025, our investigator observed pear harvest bins placed directly on the ground during harvest at the Bragg Orchard. When full bins were picked up in the orchards, using pack forks, clumps of grass and vegetative debris were stuck to the bottom of some bins. The investigator observed grass and vegetative debris contacting pears on at least 4 bin stacks at Bragg Orchard. The investigator also observed vegetative debris on 4 harvest bins that were stacked in cooler #(b)(4).

This is a repeat observation from the inspection conducted September 11, 2023 through September 18, 2023.

We acknowledge your response dated October 1, 2025, detailing your corrective actions. Your response included a “(b)(4)”, dated June 10, 2024, requiring employees to visually assess and monitor the harvest bins for debris, training record from September 2025, and corrective action log. We will evaluate the adequacy of your corrective actions at our next inspection.

3. Based on your agricultural water assessment, you did not determine and document whether measures under 21 CFR 112.45 are reasonably necessary to reduce the potential for contamination of covered produce, as required by 21 CFR 112.43(c).

On September 16, 2025, our investigator observed that the annual water risk assessment for EVO orchard documented the use of overhead irrigation where water makes direct contact with pears within three days before harvest. The assessment also determined that the rest of the orchards are irrigated using micro sprinklers that are not intended to contact covered produce; however, low-hanging fruit or foliage may be positioned within the spray pattern. Your farm stated that (b)(4). Based on this testing, the investigator’s review of your water testing documentation identified:

(b)(4)

The assessment identified sources and conditions that are reasonably likely to introduce contamination to the irrigation water, but did not include written mitigation measures to reduce the potential for contamination of covered produce.

We acknowledge your response dated October 21, 2025, detailing your corrective actions; however, we are unable to evaluate the adequacy of your corrective actions. Your response included a new SOP titled “(b)(4),” a corrective action log, and a blank “(b)(4)” monitoring record. Your SOP includes several general mitigation measures, and instructs readers to “see the attached (b)(4) risk assessment.” However, a risk assessment was not attached. We remind you that your risk assessment is required to include documentation of the determination as required under 21 CFR 112.43(c) and to explain which mitigation measures under 21 CFR 112.45 are reasonably necessary to reduce the potential for contamination associated with the specific hazards identified in the assessment. 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 farm 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 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 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.

Please send your reply to the Food and Drug Administration, Attention: Rochelle R. Blair, Compliance Officer, Center for Food Safety and Applied Nutrition, Food and Drug Administration 5001 Campus Drive, College Park, MD 20740, or electronically to producefarminspection@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact Rochelle R. Blair at (949) 608-4496 or at producefarminspection@fda.hhs.gov.

Sincerely,
/S/

Thomas Kuntz
Acting Deputy Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
U.S. Food and Drug Administration