WARNING LETTER

Livestock Nutrition Center MARCS-CMS 698817 — April 11, 2025

Delivery Method:: Via Email
Product:: Animal & Veterinary

Recipient:: Recipient Name

Mr. Ben Baer; Recipient Title

Executive Chair of the Board; Livestock Nutrition Center; 11225 College Blvd Suite #330
Overland Park, KS 66210
United States; BenBaer@LNC-ONLINE.com

Issuing Office:: Center for Veterinary Medicine; United States

WARNING LETTER
CMS# 698817

April 11, 2025

Dear Mr. Baer:

The U.S. Food and Drug Administration (FDA) inspected your animal food manufacturing facility (non-licensed medicated and non-medicated feed mill), located at 3680 W. Jones Ave., Garden City, KS 67846-9708 from August 29 through September 17, 2024. This inspection was initiated in response to a Reportable Food Registry (RFR) report your firm filed involving multiple animal deaths after those animals consumed your firm’s non-medicated feed, LNC Pasture Gold 24-5 Plus, lot #7153, manufactured by your firm on August 20, 2024. We acknowledge your written responses dated October 1, 2024, October 29, 2024, December 3, 2024, and January 30, 2025. The FDA and your third-party lab analyzed samples of feed from a customer, as well as your retention sample. The FDA-conducted lab analysis identified the presence of monensin (a medicated feed ingredient) in your firm’s LNC Pasture Gold 24-5 Plus, which it was not formulated or labeled to include. If manufactured appropriately, medicated cattle feed containing monensin is safe for use in cattle only and may result in toxic reactions if consumed by unapproved species, such as horses.¹ Based on the sample results, necropsy reports, and other diagnostic findings from the animals that consumed this feed, the evidence indicates that those animals died from monensin toxicity. On August 26, 2024, your firm initiated a voluntary recall of this product.

During the inspection, FDA investigators found evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements in Title 21, Code of Federal Regulations, Part 507 (21 CFR 507) which cause your products to be adulterated.² The doing of any act to a food after shipment of the food and/or its components in interstate commerce and while the food is held for sale (whether or not the first sale) that results in the food being adulterated or misbranded is prohibited.³ Failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls requirements of 21 CFR Part 507 (located in subparts A, C, D, E, and F of Part 507) is a prohibited act.⁴

In addition, FDA collected a sample of your LNC Pasture Gold 24-5 Pellet, a non-medicated animal food manufactured at your facility, from a customer who reported multiple animal deaths. The subsamples were found to contain between 638 mg/kg and 2110 mg/kg of monensin. The presence of monensin in your non-medicated animal food causes the food to be unsafe because the new animal drug was not used in conformance with the drug approval.⁵ As a result, the animal food containing the new animal drug is adulterated.⁶

You may find the FDA’s regulations and the FD&C Act through links on the FDA’s homepage at http://www.fda.gov.

At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations. We acknowledge your written responses dated October 1, 2024, October 29, 2024, December 3, 2024, and January 30, 2025. We have reviewed your responses and address them below.

Hazard Analysis and Risk-Based Preventive Controls Requirements

Your animal food facility is subject to the hazard analysis and risk-based preventive controls requirements found in 21 CFR Part 507, subparts A, C, D, E, and F. During the inspection of your facility, the FDA Investigator identified a significant violation of these requirements:

You failed to sufficiently assess the probability that a hazard will occur in the absence of preventive controls, as required by 21 CFR 507.33(c)(1).

Specifically, your firm’s Food Safety Plan dated August 29, 2024, failed to identify and evaluate the known or reasonably foreseeable hazard of cross-contamination from an animal drug at the mixing stage. Your firm’s Food Safety Plan includes two hazard analyses, “Mainline Flow Chart: Hazard Analysis” and “LNC Ingredient Hazard Analysis.” Your “Mainline Flow Chart: Hazard Analysis” identifies the processing steps of “(b)(4)” and “(b)(4)” as having potential chemical hazards related to chemicals or medications used in your feeds. Your “Ingredient Hazard Analysis” identifies a potential chemical hazard for the ingredient Rumensin 90 (monensin), as well as other medicated articles used by your firm. Your firm institutes prerequisite programs to minimize the risk of contamination, including drug reconciliation, (b)(4) and (b)(4), dedicated bins, ensuring all bins are empty, standard operating procedures (SOPs), and current good manufacturing practices (CGMPs).

These prerequisite programs are inadequate. For example, on August 20, 2024, your firm manufactured and shipped non-medicated animal feed with a concentration of monensin of at least 1,810 g/ton, an ingredient the feed was not formulated or labeled to include. Specifically, you manufactured LNC Rumensin 5 Pellet, a Type B medicated feed. Directly after manufacturing LNC Rumensin 5 Pellet, you manufactured LNC Pasture Gold 24-5 Pellet, a non-medicated animal feed, in the same (b)(4), which resulted in incorporation of monensin in your LNC Pasture Gold 24-5 Pellet.

Your firm’s production records show your firm manufactured (b)(4) pounds of LNC Rumensin 5 Pellet and bagged approximately (b)(4) pounds leaving approximately (b)(4) pounds of product unaccounted for. Your firm’s production records also indicate you produced (b)(4) pounds of LNC Pasture Gold 24-5 Pellet, but distributed (b)(4) pounds of finished product, representing approximately (b)(4) pounds more than was manufactured. FDA lab analyses identified a concentration of 1184.4 g/ton of monensin in the LNC Pasture Gold 24-5 product. Your prerequisite programs failed to adequately safeguard against unsafe contamination from drug carryover in the absence of a preventive control.

Evaluation of your response:

In your written responses to the Form FDA 483 dated October 1, 2024, October 29, 2024, December 3, 2024, and January 30, 2025, you stated your investigation determined that a malfunctioning sensor in the (b)(4) caused your computer-controlled batching system to stop the cleanout process of the (b)(4) before the remaining product could be discharged from the (b)(4). Additionally, you stated you had not identified yield tolerance for each run of food your firm manufactures. You also provided invoices for the replacement of the (b)(4), updated SOP 18 – “Mixing Plan,” implemented SOP 100 – “Feed Variance for finished and bulk feeds,” updated SOP 4 – “(b)(4),” updated SOP 12A – “(b)(4) Test Carryover Plan,” provided training for relevant SOPs, and included production records. Your SOP 18 now includes a visual inspection of the (b)(4) for all Type B medicated feeds and your SOP 100 now includes a (b)(4) yield tolerance for all finished bagged and bulk feeds. You added logic for the (b)(4) indicator to operate in a failsafe mode. You also indicated that you’ve conducted (b)(4) testing for Type B medicated feeds and updated the (b)(4) amounts in your SOP 4 accordingly.

However, we have noted the following inadequacies in your responses:

1. Your responses do not address if you’ve evaluated the food safety risk of other feeds you manufactured that could have potentially been impacted due to the malfunctioning sensor.
2. Your updated SOP 18 discusses the addition of a visual inspection of the (b)(4) after each Type B medication production run to ensure the (b)(4) is free from medicated feed carryover, but fails to identify how these inspections will be documented or verified.
3. Your responses address the mixing system at your facility, but do not address (b)(4) procedures for other stages of production, such as post-mixing product bins, pelleting, or bagging lines.

Conclusion

This letter is not intended to be an all-inclusive statement of 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 and FDA regulations.

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

For more information about FDA’s current thinking on the requirements of 21 CFR Part 507, see:

Guidance for Industry #235: “Current Good Manufacturing Practice Requirements for Food for Animals”, https://www.fda.gov/media/97464/download.
Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals”, https://www.fda.gov/media/110477/download
Draft Guidance for Industry #246: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program”, https://www.fda.gov/media/113923/download

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 correct 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 fifteen (15) working days, state the reason for the delay and the time frame within which you will complete the correction. If you believe your products are not in violation of the Act and FDA regulations, include your reasoning and any supporting information for our consideration.

The Food & Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance is encouraging electronic submission of any response you choose to submit to this letter. We encourage you to submit files up to 100 megabytes in a single email, and to divide files greater than 100 megabytes so they may be submitted as smaller files in separate emails. If you submit electronic correspondence, please ensure that your facility’s name, the CMS number at the top of this letter, and the inspection location are included in your correspondence. We intend to issue an electronic acknowledgement upon receipt of your email.

Please direct your electronic correspondence, and any follow-up questions regarding this letter, to Compliance Officer Chad J. Whitwell at Chad.Whitwell@fda.hhs.gov.

If you have questions regarding this letter, please contact Compliance Officer Chad Whitwell by telephone at (214) 253-5328, or by email at Chad.Whitwell@fda.hhs.gov.

Sincerely,
/S/

Isaac K. Carney
Director of Food Compliance, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
U.S. Department of Health and Human Services

Distribution:
cc: Lon (Sam) E. Huntley, Location Facility Manager
Livestock Nutrition Center, LLC
3680 W. Jones Ave.
Garden City, KS
Sam.Huntely@LNC-ONLINE.com

___________________________

1 See 21 CFR 558.355(d)(7)(i).

2 See Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C § 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).

3 See Section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].

4 See Section 301(uu) of the FD&C Act [21 U.S.C. 331(uu)].

5 See Section 512(a)(2) of the FD&C Act [21 U.S.C. § 360b(a)(2)].

6 See Section 402(a)(2)(C)(ii) and 501(a)(6) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(ii)] and [21 U.S.C. § 351(a)(6)].