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August 14, 2023

WARNING LETTER

Dear Mr. Debertin,

The Nebraska Department of Agriculture (NDA), under U.S. Food and Drug Administration (FDA) contract, conducted an inspection of your licensed medicated and non-medicated animal feed manufacturing facility, located at 1500 E Omaha Ave, Norfolk, NE 68701, on January 25, 31, and February 15, 2023. This inspection was initiated as a follow-up to a Reportable Food Registry (RFR) report your firm filed after receiving a consumer complaint involving the deaths of 17 head of cattle after consuming a non-medicated animal feed, “PN 16-8-12 Mineral R-1G” lot # M217160, manufactured by your facility. The NDA collected a sample of this lot of animal food from the farm reporting the cattle deaths. The laboratory analysis found your product contained excessive levels of non-protein nitrogen (NPN) in the form of urea. The elevated level of NPN in your product named above causes it to be adulterated because it renders the food injurious to the health of cattle.¹ On January 20, 2023, you initiated a voluntary recall of this product. On January 25, 2023, you expanded this recall to include “PN 16-8-12 Mineral R-1G” lot# M217170 due to the presence of excess urea.

The inspection revealed evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF) regulation, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507) which also cause your products to be adulterated.² The doing of any act to a food or drug after shipment of the food or drug and/or its components in interstate commerce and while the food or drug is held for sale (whether or not the first sale) that results in the food or drug being adulterated or misbranded is a prohibited act.³ Further, 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) is also a prohibited act.⁴ In addition, the inspection revealed evidence of significant violations from the Current Good Manufacturing Practice for Medicated Feeds regulations, 21 CFR Part 225, which also cause your medicated feeds to be adulterated.⁵ 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 (FDA-483). We acknowledge your written response dated March 17, 2023. We have reviewed your response 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 NDA Investigators noted evidence of significant violations of these requirements:

1. 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 you manufacture, process, pack, or hold at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 507.33(a).

a) Your hazard analysis did not identify nutrient toxicity as a known or reasonably foreseeable hazard. You use urea as an ingredient to manufacture food for cattle. Urea has a known or reasonably foreseeable hazard of nutrient toxicity because elevated levels of urea can cause serious health issues and death in ruminant animals such as cattle and sheep.

b) Additionally, your hazard analysis did not identify and evaluate mycotoxin, specifically deoxynivalenol (DON or vomitoxin), fumonisin, and aflatoxin, as known or reasonably foreseeable hazards. You use grain and grain co-products such as wheat middlings, dried distillers grains, and corn as ingredients to manufacture animal food. These grains are known to be susceptible to mycotoxin contamination.

Evaluation of your response:
Your response to the FDA-483 included a revised “Dry Feed Hazard Analysis” which upon review does not fully address the known or reasonably foreseeable hazard of nutrient toxicity related to the use of urea in your food for cattle. Further, your response does not indicate that you evaluated the likelihood of urea carryover at each step of your process where the hazards associated with urea could be introduced or enhanced. We are unable to fully evaluate your corrective actions because you did not provide supporting documentation to demonstrate you have adequately evaluated nutrient toxicities and deficiencies at each production step where nutrient toxicities and deficiencies may be associated.

Your revised hazard analysis identifies the hazard of mycotoxins, specifically DON (vomitoxin), fumonisin, and aflatoxin. You further provided your updated mycotoxin testing procedure in your response. However, your procedure did not include specific information about how you determined an appropriate sample size to support the determinations made in your hazard analysis. In addition, the mycotoxin testing procedure did not contain details about sample preparation or testing procedures, which are important to ensure the test results are accurate. We will evaluate your practices and documents during the next inspection.

Further, we are unable to fully evaluate your corrective action because you did not provide supporting documentation to demonstrate the promised corrections have been completed or consistently implemented.

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. During the inspection of your facility, NDA Investigators observed evidence of a significant violation of these requirements, which included:

2. You did not keep the buildings, structures, fixtures, and other physical facilities of your plant clean and in good repair to prevent animal food from becoming adulterated as required by 21 CFR 507.19(a). Specifically, your bulk storage bins are not designated for one ingredient, meaning a bin previously containing urea can be filled with a different ingredient, increasing the possibility of carryover. Your firm’s root cause analysis for the presence of excessive urea in your two recalled lots of animal feed found an ingredient bin that previously contained urea was not properly cleaned prior to loading limestone. This allowed remaining urea residue to contaminate your limestone ingredient which was used to manufacture the recalled lots.

Evaluation of your response:
Your response to the FDA-483 included a revised “Dry Feed Hazard Analysis” which documents that you have identified “Ingredient Residue /Contamination” at the “Bulk Ingredient Receiving” step as not requiring a preventive control due to cleaning and flushing of the receiving pit area after receiving high-risk materials such as urea. You additionally identified a process preventive control, “Ingredient Bin Inspections and Cleanout” to prevent “Product Contamination” at the “Bulk Ingredient Storage.” However, we are unable to fully evaluate your corrective actions because you did not provide supporting documentation to demonstrate the promised corrections have been completed or consistently implemented.

Current Good Manufacturing Practice (CGMP) for Medicated Feeds Requirements
Your animal food facility is subject to the medicated feed CGMP requirements for licensed medicated animal feed manufacturers found in 21 CFR 225.1 – 225.115. During the inspection of your facility, the NDA Investigators observed evidence of significant violations of these requirements, which included the following:

3. You did not investigate and implement a corrective action when assay results showed medicated feeds were not in accord with label specifications as required by 21 CFR 225.58(d).

On October 7, 2022, the Nebraska Department of Agriculture issued two drug assay reports to your firm for PN Head Start 5 Receiver B100 lot # M065990 and PN 40-14 Grower R400 lot # M078280. Your PN Head Start 5 Receiver B100 is labeled as containing 100 g/ton of lasalocid but was found to contain 183 g/ton according to the lab report. Your PN 40-14 Grower R400 is labeled as containing 400 g/ton of monensin but was found to contain 803 g/ton according to the lab report. You did not investigate the out-of-specification results or implement any corrective actions.

Evaluation of your response
Your response to the FDA-483 states you have a “Product Non-Conformance Investigation Policy” in place, however, your employees did not follow those procedures. You additionally state that you have retrained your employees on this procedure and “disposed of the product referenced in this observation.” However, you did not provide any documentation showing you investigated the root cause of the out-of-specification feeds manufactured by your firm to ensure that such a violation does not reoccur. Therefore, we are unable to fully evaluate your corrective actions because you did not provide supporting documentation of your root cause investigation.

4. You did not perform at least three periodic assays during a calendar year for medicated feeds requiring a medicated feed mill license, as required by 21 CFR 225.58(b)(1).

a) You manufactured medicated feeds using Aureo S 700 (chlortetracycline and sulfamethazine) (b)(4) times in 2022. None of the three required assays were performed for Aureo S 700 during calendar year 2022.

b) You manufactured medicated feeds using Corid 25% (amprolium) (b)(4) times in 2022. Your firm only conducted one of the three required assays for Corid 25% during calendar year 2022.

Evaluation of your response
Your response to the FDA-483 reported a root cause analysis found the individual responsible for completing the drug assays did not utilize the check off schedule to keep track of samples that were sent in. You also stated you created a task in your internal database and document and task management system that will send a quarterly reminder to the Operations Manager and Environmental Health and Safety Team. However, we are unable to fully evaluate your corrective actions because you did not provide supporting documentation to demonstrate the promised corrections have been completed or implemented.

5. You did not maintain a daily inventory record for each drug used in the manufacture of medicated feeds that lists all the information required by 21 CFR 225.42(b)(6) for each drug by lot number. Specifically,

a) You failed to record the lot change on your Perpetual Drug Inventory Record for Aureo S 700 from MDA10022 to MDA10027. This caused you to carry over the incorrect lot number to Mix Report number M169550 which indicates that (b)(4) of Aureo S 700, lot MDA10022 was used to make feed. However, during the inspection, the NDA Investigators observed during a physical inventory examination that Aureo S 700 lot MDA10027 was the lot used in the manufacture of this run of feed.

b) You failed to record the lot change on your Perpetual Drug Inventory Record for Aureomycin 90 from CFA20170 to CFA20117. This caused you to carry over the incorrect lot number to Mix Report number M236820 which indicates that (b)(4) of Aureomycin 90, lot CFA20170 was used to make this run of feed. However, during the inspection, the NDA Investigators observed during a physical inventory examination that Aureomycin lot CFA20117 as the lot used in the manufacture of this run of feed.

c) You failed to record the lot change on your Perpetual Drug Inventory Record for Bovatec 91 from HFN220060 to HFN220260. This caused you to carry over the incorrect lot number to Mix Report number M236840 which indicates that (b)(4) of Bovatec 91, lot HFN220060 was used to make this run of feed. However, during the inspection, the NDA Investigators observed during a physical inventory examination that Bovatec 91 lot HFN220260 was the lot used in the manufacture of this run of feed.

Evaluation of your response
In your response to the FDA-483, you stated that your root cause analysis revealed your employees were not aware of how to keep track of inventory by lot number in your inventory management system and that you have implemented a daily physical drug inventory of all drugs by lot number to ensure the correct lot numbers were being identified. However, we are unable to fully evaluate your corrective actions because you did not provide supporting documentation to demonstrate the promised corrections have been completed or consistently implemented.

6. You did not maintain a drug inventory of each lot or shipment of drug by means of a daily comparison of the actual amount of drug used with the theoretical amount of drug usage in terms of the medicated feeds manufactured as required by 21 CFR 225.42(b)(7).

Specifically, during the inspection, you communicated with the investigator you do not perform a determination of the actual amount of drug in inventory at a designated point during the production day.

a) The Perpetual Drug Inventory Record for Aureo S 700 on January 25, 2023 shows a theoretical amount on hand of (b)(4) pounds of lot number MDA10022. The actual physical inventory for this drug was determined in the presence of the NDA Investigators to be 200 pounds of lot number MDA10022 and 17.15 pounds of lot number MDA10027.

b) The Perpetual Drug Inventory Record for Aureomycin 90 on January 25, 2023 shows a theoretical amount on hand of (b)(4) pounds for lot number CFA20170. The actual physical inventory for this drug was determined in the presence of the NDA Investigators to be 6,000 pounds of lot number CFA20170 and 8,018.85 pounds of lot number CFA20117.

c) The Perpetual Drug Inventory Record for Bovatec 91 on January 25, 2023 shows a theoretical amount on hand of (b)(4) pounds for lot number HFN220060. The actual physical inventory for this drug was determined in the presence of the NDA Investigators to be 1,000 pounds of lot number HFN220060 and 305.78 pounds of lot number HFN220260.

Evaluation of your response
Your response states a root cause analysis found that the actual amount of drug used, as recorded in the Perpetual Drug Inventory Record for each drug in the above-referenced feed runs, was not a physical weight determination but that your mixer operators were documenting the theoretical amount of drug in the mix rather than the actual amount weighed. You stated you have trained the employees to record the actual amount of drug they weighed out and added to the mix. Further, you stated your office administrator will use a daily physical drug inventory, drug weights listed on the mix reports, and the perpetual drug inventory to reconcile the drug inventory by lot in your inventory management system. We are unable to fully evaluate your corrective actions because you did not provide supporting documentation to demonstrate the promised corrections have been completed or consistently implemented.

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. 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.

Please send your firm’s 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. Trevor R. Odvody, Operations Manager, Battle Creek/CHS LLC dba Progressive Nutrition, 1500 E Omaha Ave, Norfolk NE 68701-6194

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

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 501(a)(2)(B) of the FD&C Act [21 U.S.C. § 351(a)(2)(B)] and 21 CFR 225.1(b)(1)