---

---

---

December 15, 2022

WARNING LETTER

CMS# 643701

Dear Mr. Baer:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your animal food manufacturing facility (non-licensed medicated and non-medicated feed mill), located at 2900 Johnson Rd., Gonzales, TX 78629 from August 18, 2022, through August 23, 2022. This inspection was initiated in response to a Reportable Food Registry (RFR) report your firm filed after receiving a consumer complaint involving multiple illnesses and deaths in one of your customer’s fallow deer herds after consuming a non-medicated deer feed (“HUGHESDEER16CPv3”) that was manufactured by your firm on (b)(4) and shipped to your customer on (b)(4). Your third-party lab analyzed samples of feed from the customer as well as your retention samples and reported the presence of monensin sodium (a medicated feed ingredient), which the deer feed was not formulated to include. 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 deer.¹ Based on the sample results, necropsy reports, and other diagnostic findings from the deer that consumed this feed, the evidence indicates that the deer died from monensin toxicity. Your firm conducted a recall of this deer feed on July 27, 2022.

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 Part 507) which causes 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

Additionally, you failed to report a reportable food to the Reportable Food Registry (RFR) within twenty-four hours of determining that an animal food is a reportable food (i.e., an animal food for which there is a reasonable probability that the use of, or exposure to, such animal food will cause serious adverse health consequences or death to animals).⁵ Failure to submit a required reportable food report is a prohibited act.⁶

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

At the conclusion of our inspection, you were issued a Form FDA 483, Inspectional Observations. We received your firm’s written email responses to these observations dated September 2, September 23, October 4, October 7, October 24, November 1, and November 30, 2022, and address your corrective actions below, in relation to each of the noted violations.

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 Investigators obtained evidence of significant violations of these requirements, which included but were not limited to the following:

You did not conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 507.33(a).

Specifically, your revised Food Safety Plan and written Hazard Analysis dated August 2, 2022, failed to identify and evaluate the following

a. The known or reasonably foreseeable hazard of a drug resulting in cross-contamination at the receiving step. On (b)(4), your firm received and unloaded the feed ingredient, LNC Rumensin 5 Pellet, containing (b)(4) grams/ton of monensin, into a (b)(4)ton holding tank which was designated for holding Fortipel Calf pellets, a feed ingredient that does not contain monensin. As a result, the medicated feed ingredient was commingled with the non-medicated feed ingredient. On (b)(4), your firm used pellets from this commingled tank to manufacture (b)(4) tons of the non-medicated deer feed, “HUGHESDEER16CPv3”, which resulted in the recall described above.

Evaluation of your responses:
In your written responses to the Form FDA 483, you stated you changed from receiving loose “Rumensin 5 pellets” in bulk to receiving them packaged in bagged containers, and you implemented a new preventive control titled, “Medicated Reconciliation Plan” (SOP #17), to monitor the (b)(4) inventory of medicated feed ingredients. We are unable to evaluate the adequacy of your responses because, although you provided a copy of SOP #17 for review, you failed to provide an updated hazard analysis or any examples of completed documentation demonstrating the SOP has been implemented.

After filing the RFR report and before our inspection, you conducted a reanalysis of your hazard analysis, dated August 2, 2022. However, while your written responses state that you have changed to receiving bagged “Rumensin 5 pellets”, you have not provided an updated hazard analysis that evaluates all hazards associated with medicated ingredients, such as drug carryover. Furthermore, you have not provided an updated hazard analysis that identifies the use of SOP #17 as a preventive control or that specifies at what step it is applied. We encourage you to provide documentation to show that corrections have been implemented, and we will verify the implementation of your corrective actions during the next inspection.

b. The known or reasonably foreseeable hazards of fumonisin and deoxynivalenol (DON or vomitoxin) for all grains and their co-products you receive, store, and use at your facility that are susceptible to fumonisin and vomitoxin, including, but not limited to, corn, dried distillers grains (DDGs), and cotton seed.

Evaluation of your responses:
In your written responses to the Form FDA 483, you stated your firm conducted an evaluation of feed volumes by animal species to determine the scope of species risks for fumonisin and DON. You also stated that you will assess the severity and probability of mycotoxin risks for each grain and grain co-product ingredient and provided SOPs outlining your new aflatoxin and fumonisin testing plans for corn and DDGs.

Your responses are inadequate due to the following:

• Regarding your evaluation of DON, your response states you have decided not to include this toxin in your testing panel since you do not use wheat products, corn and corn byproducts do not generally have elevated levels of DON, and your species mix is (b)(4)% beef cattle. However, FDA has published advisory levels for DON in ingredients such as DDGs and in total rations for cattle.⁷ Your response does not address our concerns related to the hazard of DON in feed.
• You identified aflatoxins as a known or reasonably foreseeable hazard in some of your grain and grain co-product ingredients. However, you failed to identify aflatoxins as a hazard for cotton seed hulls and soy hull pellets, which are grains that are susceptible to aflatoxins.

Additionally, we are unable to fully assess the adequacy of your responses because you failed to provide documentation, such as an updated hazard analysis or testing and training records, demonstrating that corrective actions have been implemented.

Reportable Food Registry (RFR)

You failed to report a reportable food to the RFR within 24 hours of determining that an article of food is a reportable food (an article of food for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals), as required by section 417(d)(1) of the FD&C Act. Your reportable food report also failed to include data elements listed in section 417(e), as required by section 417(d)(1) of the FD&C Act.

Specifically, on July 22, 2022, you were informed by your customer that a nonmedicated custom animal food you manufactured, “HUGHESDEER16Pv3,” had been implicated in multiple illnesses and deaths of deer that had consumed it. The customer told you that a feed analysis by the (b)(4) and preliminary necropsy results indicated the cause of death was monensin toxicity. Therefore, you determined on July 22, 2022, that your “HUGESDEER16Pv3” was a reportable food. During the next week, additional laboratory analysis reports from the customer and analysis of your retain samples of “HUGHESDEER16vPv3” further indicated the presence of monensin in the non-medicated deer feed. However, you did not file the reportable food report until August 1, 2022.

Additionally, a reportable food report submitted shall include certain data elements prescribed by the FD&C Act,⁸ such as the extent and nature of adulteration and the disposition of the articles of food, when known.⁹ Your root cause investigation identified multiple lots of animal food manufactured by your facility between (b)(4), that may have been affected by monensin cross contamination. On July 27, 2022, you contacted your customers who received feed during this timeframe to notify them and request they return any unused feed. However, the reportable food report you submitted only addresses contamination of the “HUGHESDEER16CPv3” animal food and does not address other implicated lots of animal food. Furthermore, the reportable food report states the “HUGHESDEER16CPv3” product was not recalled, but the actions you took to remove marketed product is considered a recall.

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 or regulatory action, 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
• 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 within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.

Your written response should be sent to Chad J. Whitwell, Compliance Officer, at chad.whitwell@fda.hhs.gov (preferred) or at U.S. Food and Drug Administration, 1201 Main St, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues in this letter, please contact Mr. Whitwell at 214-253-5328.

Sincerely,
/S/

Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director

cc: Mr. Maurice G. Janda, Location Fulfillment Manager
Livestock Nutrition Center, LLC
2900 Johnson Rd.
Gonzales, TX 78629

cc: Mary Sasser, Program Director
Office of the Texas State Chemist
ATTN: Mary Sasser, Program Director
P.O. Box 3160
College Station, TX 77841-3160

__________________________

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

2 See Section 402(a)(4) of the 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 417(d) of the FD&C Act [21 U.S.C. § 350f(d)].

6 See Section 301(mm) of the FD&C Act [21 U.S.C. § 331(m)].

7 Guidance for Industry and FDA: Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for Human Consumption and Grains and Grain By-Products used for Animal Feed | FDA (https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/guidance-industry-and-fda-advisory-levels-deoxynivalenol-don-finished-wheat-productshuman#:~:text=The%20advisory%20levels%20for%20DON,potentially%20be%20consumed%20by%20humans.)

8 See Section 417(d)(1)(A) of the FD&C Act [21 U.S.C. § 350f(d)(1)(A)].

9 See Section 417(e)(4) and (6) of the FD&C Act [21 U.S.C. § 350f(e)(4) and (6)].