---

---

---

May 11, 2023

WARNING LETTER

Ref: CMS Case 651534

Dear Mr. Neugebauer:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your animal food manufacturing facility located at 33445 County Road 11, Manzanola, Colorado, between the dates of December 14, 2022, and February 1, 2023. The inspection was conducted as part of our investigation into a multi-state foodborne outbreak of Clostridium botulinum toxicosis implicated in approximately fifty-two equine deaths and additional illnesses.

As part of our investigation, a sample (FDA sample 1210120) of your “TOP OF THE ROCKIES HORSE CUBES (ALFALFA HAY IN A BAG),” lot 111422, collected by the Louisiana Department of Agriculture and Forestry (LDAF) from an unopened bag, was analyzed by FDA. Our analysis confirmed the presence of preformed Clostridium botulinum toxin type C. Additionally, our analysis confirmed the presence of animal hair in your product. Clostridium botulinum toxin type C can cause serious adverse health consequences or death to equines and is known to be associated with ingestion of animal food containing animal carcasses contaminated with the toxin.¹ The presence of Clostridium botulinum toxin type C and animal hair in your product causes it to be adulterated.^{2, 3}

On December 12, 2022, you initiated a voluntary recall of your Top of the Rockies horse cubes, which ultimately included lots 111222, 111322, 111422, 111522, and 111622.⁴

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 regulation, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507), which cause your products to be adulterated.⁵ Introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.⁶ Additionally, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive control provisions of 21 CFR Part 507 (located in subparts A, C, D, E, and F of Part 507) is a prohibited act.⁷

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

At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your written response, submitted by your attorney on your behalf, dated February 22, 2023. We have reviewed your response and address your corrective actions below, in relation to each of the noted violations.

Current Good Manufacturing Practice (CGMP) Requirements

Your animal food facility is subject to the CGMP requirements found in 21 CFR Part 507, subparts A, B, and F. Our inspection identified a significant violation of these requirements.

1. You did not examine raw materials and other ingredients to ensure that they are suitable for manufacturing and processing into animal food and are handled under conditions that will protect against contamination and minimize deterioration as required by 21 CFR 507.25(b)(1).

Our investigators observed your firm using alfalfa hay bales that are approximately 3 feet by 4 feet by 8 feet and, therefore, have significant internal volume, in the manufacture of your alfalfa cubes. Your practice of inspecting only the exterior of these large hay bales is not adequate to identify the presence of an animal carcass baled into the hay that would render it unsuitable for manufacturing into animal food. As a result, foodborne disease outbreaks like the one described above could occur.

Evaluation of your response:
Your response states you dispute the FDA’s observation because you inspect the exterior of each hay bale for foreign objects and it is impractical to inspect the interior of hay bales, and/or inspection “should be done at the local/farmer level, not by Manzanola.” You also stated you were reviewing your processes to consider whether additional measures can be implemented, including researching the possibility of using an X-ray or similar machine and implementing “more intense visual inspections.”

As a manufacturer of animal food, you are responsible for ensuring the food you introduce into interstate commerce is not adulterated, including complying with the CGMP requirements of Part 507. For the reasons stated above, your practice of inspecting only the exterior of large hay bales is not sufficient, and your response is inadequate because you have not yet implemented corrections to ensure the interior of the large bales you use to make your product are not contaminated with animal carcasses.

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. Our inspection identified a significant violation of these requirements.

2. You did not prepare, or have prepared, and did not implement a written food safety plan, as required by 21 CFR 507.31(a). The preparation of the food safety plan must be overseen by your preventive controls qualified individual (PCQI), as required by 21 CFR 507.31(b), and must include the following, in accordance with 21 CFR 507.31(c):
    a. The written hazard analysis as required by 21 CFR 507.33(a)(2);
    b. The written preventive controls as required by 21 CFR 507.34(b);
    c. The written supply-chain program as required by subpart E of 21 CFR Part 507;
    d. The written recall plan as required by 21 CFR 507.38(a)(1);
    e. The written procedures for monitoring the implementation of the preventive controls as required by 21 CFR 507.40(a);
    f. The written corrective action procedures as required by 21 CFR 507.42(a)(1); and
    g. The written verification procedures as required by 21 CFR 507.49(b).

During the inspection, you told our investigator that you did not have a food safety plan. At the close of the inspection, you indicated you had developed a food safety plan, but it did not identify Clostridium botulinum as a known or reasonably foreseeable hazard. There is a known association between illness caused by Type C botulism and the ingestion of animal food containing animal carcasses contaminated with the preformed Clostridium botulinum toxin Type C.⁸ Furthermore, as described above, one lot of your animal food has previously been shown to contain botulinum toxin. You stated you could revise the food safety plan.

Evaluation of your response:
In your response, you stated it was unclear as to whether Manzanola was required to have a food safety plan, but regardless, you created a food safety plan and provided a copy. As a facility that manufactures, processes, packs, and holds animal food for consumption in the United States, you are required to register as a food facility, unless your facility qualifies for an exemption. See 21 CFR 1.225 and 1.226. (b)(3)(A), you are subject to the requirements found in 21 CFR Part 507, including the requirement for a food safety plan, unless you meet one of the exemptions outlined in 21 CFR 507.5, or you are a Qualified Facility and as such subject only to the requirements outlined in 21 CFR 507.7. FDA is unaware of any evidence that Manzanola meets any of the exemptions from Part 507 or meets the Qualified Facility definition of 21 CFR 507.3.

We reviewed the Food Safety Plan you provided as part of your response and found your plan is inadequate. Despite your recent recall, our Form FDA 483, and our investigator’s discussion with you during the closeout meeting about Clostridium botulinum as a known or reasonably foreseeable hazard for the type of animal food manufactured, processed, packed, and held at your facility, your written hazard analysis does not identify and evaluate any hazards associated with the animal food at your facility, as required by 21 CFR 507.33. Furthermore, you allude to hazards in your “Ingredient/Processing Step”; however, you did not specifically identify those hazards and assess the severity of illness or injury to humans or animals if the hazards were to occur or the probability that the hazard will occur in the absence of a preventive control, as required by 21 CFR 507.33(b) and (c). For example, your hazard analysis describes the processing step (b)(4) that are used to remove any foreign object.” However, under the column for potential food safety hazards at this step, you have “NO” listed for physical hazards. FDA has resources available online to assist firms in developing food safety plans.⁹ We encourage you to reevaluate your Food Safety Plan and provide us with any updates and changes you make.

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’s regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to legal 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
• “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 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 addressed to the U.S. Food and Drug Administration; Attn: Hanna L. Potter, Compliance Officer; 6th Ave and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado, 80225-0087 or via email at hanna.potter@fda.hhs.gov. If you have questions about this matter, you may contact Ms. Potter at (303) 236-3094.

Sincerely,
/S/

E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West Division 4

cc: Hollis Glenn
Colorado Department of Agriculture
305 Interlocken Parkway
Broomfield, CO 80021

(b)(4)

_________________________________

1 “Botulism in Horses” (https://www.merckvetmanual.com/horse-owners/disorders-affecting-multiple-body-systems-of-horses/botulism-in-horses)

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

3 See Section 402(a)(3) of the FD&C Act [21 U.S.C. § 342(a)(3)]

4 Manzanola Feeds is Recalling Certain Lots of Top of the Rockies Alfalfa Cubes due to Possible Clostridium botulinum Health Risk | FDA (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/manzanola-feeds-recalling-certain-lots-top-rockies-alfalfa-cubes-due-possible-clostridium-botulinum#recall-announcement).

5 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).

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

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

8 “Type C botulism in dairy cattle from feed contaminated with a dead cat” (https://journals.sagepub.com/doi/pdf/10.1177/104063870001200302) and “Botulism” (https://www.sciencedirect.com/science/article/pii/S0749073917302596?via%3Dihub).

9 Food Safety Plan Builder | FDA (https://www.fda.gov/food/food-safety-modernization-act-fsma/food-safety-plan-builder)