- Delivery Method:
- VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
- Animal & Veterinary
Food & Beverages
Recipient NameDr. Michael P. Johll
Recipient TitleMajority Owner/VP/COO
- Suther Feeds, Inc.
105 S. Kansas Avenue
Frankfort, KS 66427-1331
- Issuing Office:
- Division of Human and Animal Food Operations West II
August 21, 2023
CMS # 653966
Dear Dr. Johll,
The U.S. Food and Drug Administration (FDA) inspected your animal food manufacturing facility (feed mill) located at 105 4th St, Clay Center, Kansas on January 24 through January 30, 2023. The inspection was conducted as a follow-up to a Reportable Food Registry (RFR) report regarding suspected monensin poisoning from a medicated feed that resulted in numerous cattle deaths. A sample of your medicated cattle feed labeled as “(b)(4)” for beef cattle was collected by FDA on January 27, 2023. Analysis of the feed found it contained a super potent concentration of monensin at (b)(4) grams/ton, which is above the labeled monensin concentration of 20 grams/ton. On January 10, 2023, you initiated a voluntary Class I recall of this animal food due to excessive monensin.
During the inspection, the FDA Investigator found evidence that you manufactured and distributed a cattle feed, “(b)(4)” that contained a super-potent concentration of the new animal drug monensin. This Type C medicated cattle feed containing the Type A medicated article of monensin is unsafe because the new animal drug was not used in conformance with the drug approval.1 As a result, the animal feed containing the new animal drug is adulterated.2
In addition, FDA’s Investigator found evidence of a significant violation of the Current Good Manufacturing Practice for Medicated Feeds requirements found in Title 21, Code of Federal Regulations, Part 225 (21 CFR Part 225). Failure of your medicated feed mill to comply with these requirements causes your medicated feed to be adulterated.3
Furthermore, the inspection revealed 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 cause your products to be adulterated.4 Failure of the owner, operator, or agent in charge of a covered facility to comply with the CGMP and preventive controls provisions 21 CFR Part 507 is a prohibited act.5
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.6
You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). We received your written responses on February 9, March 1, and April 5, 2023. We have reviewed your responses and address your corrective actions below.
Current Good Manufacturing Practice (CGMP) for Medicated Feed Requirements
Your animal food facility is subject to the medicated feed CGMP regulations for licensed, medicated animal feed manufacturers found in 21 CFR 225.10-225.115. During the inspection of your facility, the FDA Investigators noted evidence of significant violations of these requirements, which included the following:
1. You failed to properly identify, handle, and control drugs in the mixing areas to maintain their integrity and identity, as required by 21 CFR 225.42(b)(4).
Specifically, on January 4, 2023, you reworked approximately (b)(4) of Type C grain mix mineral for beef cattle labeled as “(b)(4)” with lot number 3010333. You added approximately (b)(4) of (b)(4) Type A Medicated Article ((b)(4) monensin), lot number E062904 into the batch when the formula called for (b)(4) of (b)(4) Type B medicated feed ((b)(4) grams/ton monensin), which resulted in a super potent concentration of monensin in the feed. You delivered (b)(4)7 of this batch of cattle feed on January 4, 2023, to your customer. The feeding directions on your label for this cattle feed, which are in conformance with the drug approval, stated to feed at a rate of 5 to 20 pounds/head/day to provide 50 to 200 milligrams monensin/head/day. Based on the (b)(4) delivered, cattle fed from lot number 3010333 at the labeled rate would consume approximately (b)(4) to (b)(4) milligrams monensin/head/day which is not in conformance with the drug approval.8 You reported that numerous cattle died after eating this feed.
Evaluation of your response:
Your February 9, 2023 FDA 483 response stated you would create and implement a formula review and verification procedure that would include having the (b)(4) operator and mixer operators initial the (b)(4) sheet. You indicated this would be completed by February 15, 2023. In your update to the FDA 483 response dated March 1, 2023 you stated your corrective action has been completed. However, we are unable to fully evaluate your corrective actions since you did not provide supporting documentation to demonstrate the promised corrections have been consistently implemented and that they will ensure the correct drug ingredient will be selected and used.
2. You did not perform a daily comparison of the actual amount of drug used with the theoretical drug usage, as required by 21 CFR 225.42(b)(7).
Review of ten days of your drug inventory records between July 19, 2022 and January 2, 2023 revealed that although you are recording the daily usage for the animal drugs currently on site, you are not completing a daily comparison of the theoretical daily usage with the actual inventory on hand.
You use category I and II Type A medicated articles and category II Type B medicated feed as an ingredient in the manufacturing of approximately (b)(4) of Type C medicated feed (b)(4). The daily comparison between theoretical and actual drug use assists in ensuring proper drug use. Had you been following these requirements and compared the theoretical inventory to the actual inventory, you may have found the discrepancy in the Type A or Type B quantities and realized the wrong ingredient had been used and been able to hold or recall the (b)(4) product sooner.
Evaluation of your response:
Your February 9, 2023 FDA 483 response stated that you are developing a reconciliation procedure which would evaluate between actual and theoretical inventories of medications used/sold. This procedure was stated to be completed by February 15, 2023. In your update to the FDA 483 response dated March 1, 2023 you stated that as of February 28, 2023, the daily reconciliation by the mill manager was being performed on a daily basis to reconcile theoretical and actual usage of all medications in the facility. However, you did not provide a copy of the procedure or explain what processes were implemented. Therefore, we are unable to fully evaluate your corrective actions since you did not provide supporting documentation to demonstrate the promised corrections have been completed and consistently implemented.
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:
3. 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, 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).
Specifically, you told the FDA investigator that you did not have a food safety plan.
Evaluation of your response:
Your February 9, 2023 FDA 483 response stated your food safety plan would be completed by March 1, 2023. In your March 1, 2023 update to the FDA 483 response you extended this target completion date to April 15, 2023. Your April 5, 2023 response indicated you are continuing to work on your hazard analysis, standard operating procedures, and employee training. However, you have not provided your food safety plan following the target completion date of April 15, 2023. Therefore, we are unable to evaluate your corrections since you have not provided documentation that you have completed and fully implemented your food safety plan.
Current Good Manufacturing Practice (CGMP) Requirements for Animal Food
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, the FDA Investigator identified a significant violation of these requirements:
4. You failed to evaluate and use raw materials and other ingredients susceptible to contamination with mycotoxins or other natural toxins in a manner that does not result in animal food that can cause injury or illness to animals or humans, as required by 21 CFR 507.25(b)(2).
Specifically, you receive, store, and use grain and grain co-products susceptible to mycotoxin contamination, including corn, dried distillers grain, and wheat midds, in animal food at your facility. However, you do not have procedures or conduct testing to determine whether mycotoxins, such as aflatoxin, fumonisin, or deoxynivalenol (DON), are present in these ingredients or in your finished product. During the inspection, your staff confirmed that you do not have procedures for mycotoxins, including that you do not test for them.
Evaluation of your response:
Your February 9, 2023 FDA 483 response stated you would be requesting Certificates of Analysis from suppliers, reviewing the Certificates of Analysis, and conducting quarterly random testing for mycotoxins by March 1, 2023. In your update to the FDA 483 response dated March 1, 2023 you extended this target completion date to April 25, 2023. You reported that you “[h]ave received and reviewed the COA’s on a couple of loads of DDG” and were in contact with mycotoxin testing companies to evaluate options for in house testing or an offsite facility to test corn for mycotoxins. Your April 5, 2023 response indicated you are continuing to work on your food safety plan, creating standard operating procedures, and conducting training for employees. However, your responses did not provide specifics about your new target completion dates and tasks that are in progress.
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.
Additionally, please note the following:
1. FDA has determined that your facility is subject to the registration requirement in the FD&C Act9 and its implementing regulations.10(b)(4).
Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at www.access.fda.gov.
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”
• Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals”
• Draft Guidance for Industry #246: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program”
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 Danial S. Hutchison, 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 Hutchison at 913-495-5154.
LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Foods West Division II
Cc: Jerry Suther, President and CEO, Suther Feeds, Inc., 105 4th Street, Clay Center, KS 67432
1 See Section 512(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 360b(a)(2)(A)].
2 See Section 501(a)(6) of the FD&C Act [21 U.S.C. § 351(a)(6)].
3 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).
4 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)
5 See section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)]
6 See section 301(k) of the FD&C Act [21 U.S.C. § 331(k)] and section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]
7 Your records do not document the source of the additional 900 pounds that were delivered.
8 The lethal dose at which 50% of exposed cattle will die (LD50) of monensin toxicity is estimated to be 26.4 milligram/kilogram (12 milligram/pound) of body weight. (See Joseph Deen Roder, Ionophore Toxicity and Tolerance, Veterinary Clinics of North America: Food Animal Practice, Volume 27, Issue 2, July 2011, Pages 305-314, available at http://dx.doi.org/10.1016/j.cvfa.2011.02.012.) Therefore, for 600-pound animals, such as those owned by your customer, the LD50 is estimated to be 7,200 mg.
9 See section 415 of the FD&C Act [21 U.S.C. § 350d]
10 See 21 CFR Part 1, Subpart H