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August 02, 2022

WARNING LETTER

CMS # 629638

FEI: 1913396

Dear Mr. Nelson,

The U.S. Food and Drug Administration (FDA) conducted an inspection of your animal food manufacturing facility (feed mill) located at 3154 East US Highway 24 Beloit, KS 67420 on February 14 through 24, 2022. The inspection was initiated as a follow-up to a voluntary Class I recall relating to batch #BO1902029 of the animal food product, Blueprint Lamb Grower 16% B30, which contained an elevated level of copper, as determined by your third-party laboratory. The recognized maximum tolerable level of copper in food for sheep is 15 ppm on a dry matter basis, assuming normal concentrations of molybdenum and sulfur.¹ An elevated level of copper in a sheep food product, such as the levels found in your product named above, could cause serious health issues in or be fatal to sheep.

The inspection revealed evidence of significant violations of the Hazard Analysis and Risk-Based Preventive Controls for Food for Animals requirements, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 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 The failure of the owner, operator, or agent in charge of a covered facility to comply with the hazard analysis and risk-based preventive controls provision of 21 CFR Part 507 (located in subparts A, C, D, E, and F of Part 507) is also a prohibited act.⁴

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

At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations. We received your written responses dated March 17, 2022 and March 31, 2022 and will address your corrective actions 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, an FDA Investigator noted evidence of significant violations of these requirements, which included but were not limited to the following:

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

Specifically, your reliance on your prerequisite program failed to reduce the probability that an elevated level of copper will occur in your animal food in the absence of a preventive control. Your hazard analysis identifies unsafe carryover from previous batches (of animal food) due to operator error as a known or reasonably foreseeable food safety hazard. Your hazard analysis further states this hazard does not require a preventive control because the risk is mitigated by a prerequisite program CGMP (Medicated Equipment Cleanout Procedures), including your sequencing and flushing protocol, and a (b)(4) verification of production records by management.

However, your prerequisite program was not implemented in a way that reduces the probability of occurrence, as evidenced by the elevated copper levels in samples 13764098 (38.1 ppm) and 13769906 (31.3 ppm) of two lots of sheep food that your facility collected and submitted to a third-party laboratory as part of your release program. Therefore, you did not reduce the probability that the hazard would occur in the absence of a preventive control.

Your responses to the Form FDA 483 state the root cause of the elevated level of copper in the sheep food resulted from the “unsafe carryover or cross contamination from other batches due to equipment failure and incorrect operation of equipment.” You also describe a new preventive control for the hazard of “unsafe carryover or cross-contamination from other batches due to equipment failure or incorrect operation of equipment.” This preventive control involves (b)(4) step. Your new preventive control is intended to catch incorrectly processed animal food before it is distributed. However, this is inconsistent with the role of preventive controls—to significantly minimize or prevent the hazard in the animal food (See 21 CFR 507.3).

We cannot determine the adequacy of your corrective actions since you did not describe or provide documentation to support how you would ensure the proper sequencing of batches and flushing of equipment prior to the production of sheep food to prevent unsafe carryover.

2. 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 hazard analysis identified nutrient deficiency or toxicity hazards in “Macro (Minerals, Mineral Premixes, Non-Protein Nitrogen or as defined by AAFCO)” ingredients. However, you did not evaluate the severity of the illness or injury if the hazard were to occur, or the probability that the hazard would occur in the absence of preventive controls, to determine whether the hazard requires a preventive control. The hazard analysis was incomplete for this category of ingredients. The columns for severity, probability, risk assessment, and whether a preventive control is required were blank.

We acknowledge your written responses to the Form FDA 483 dated March 17, 2022, and March 31, 2022, describing corrective actions you have taken or plan to take to address this observation, including revising your hazard analysis so that the columns associated with the chemical hazard of nutrient deficiencies or toxicities for ingredients such as non-protein nitrogen are no longer blank and incomplete. FDA will verify the implementation of these corrections during the next inspection.

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 product(s). 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. 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.

We also have the following comment:

It is important that you identify the root cause for the excess copper in your sheep food. You state that it was unsafe carryover or cross contamination from other batches, that may have been due to equipment failure. However, you did not explain what equipment failed or how it was fixed. For example, during the inspection you tightened the bolts on the motor of the conveyor connecting the (b)(4) bagging bin to the bagger, which may have improved the emptying of the bagging bin, reducing the likelihood of comingling of foods. You also stated that the unsafe carryover or cross contamination may have resulted from incorrect operation of equipment. However, you did not explain how equipment was incorrectly operated, or how you have ensured that your employees were retrained to operate equipment correctly. Furthermore, it is unclear how the sheep food came to contain excess copper if a (b)(4) with a copper content of (b)(4) ppm copper was processed and a (b)(4) flush was performed after the EZ Beef food containing (b)(4) ppm copper was processed and before the sheep food was processed. Once you identify the root cause of the incident, you can better address the problem(s) preemptively.

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 your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Please send your firm’s written response to Kevin A Beavers, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have any questions about this letter, please contact Compliance Officer Beavers at 417-873-9455 Ext 102.

Sincerely,
/S/

LaTonya M. Mitchell, Ph.D. Program Division Director
Office of Human and Animal Foods
West Division II

cc:
Mr. Thomas B. Boudreaux
Ridley USA Inc. dba Hubbard Feeds, Inc.
3154 East US Highway 24
Beloit, KS 67420

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1 The Mineral Tolerance of Animals (National Research Council of the National Academies, Second Revised Ed. 2005).

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)].