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October 20, 2021

WARNING LETTER

CMS # 614832

Dear Mr. Sorrell,

The U.S. Food and Drug Administration (FDA) conducted an inspection of your animal feed manufacturing facility located at 401 Main St., Suite A, Bartlett, Kansas on March 11, 2021, March 22, 2021, and March 24, 2021. The inspection was initiated as a follow-up to a Class I voluntary recall of a custom formulated cattle feed that was reported to have contributed to the death of approximately eighty-seven (87) cattle upon its consumption.

The inspection revealed evidence of a significant violation of the Current Good Manufacturing Practice (CGMP) regulations for non-licensed medicated animal feed manufacturers, Title 21, Code of Federal Regulations, Part 225 (21 CFR Part 225). Failure to follow these requirements causes medicated feeds and non-medicated animal foods manufactured at your facility to be adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 351(a)(2)(B)] and Section 402(a)(2)(C)(ii) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(ii)] (see 21 CFR 225.1(b)(1)).

In addition, the inspection revealed evidence that you manufactured and distributed a cattle feed 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 within the meaning of Section 512(a)(2)(A) of the FD&C Act [21 U.S.C. § 360b(a)(2)(A)] because it was not in conformance with the animal drug approval. As a result, the animal feed containing the new animal drug is adulterated under Section 501(a)(6) of the FD&C Act [21 U.S.C. § 351(a)(6)].

Finally, the inspection found evidence that this custom cattle feed is also misbranded within the meaning of Section 502(a)(1) of the FD&C Act [21 U.S.C. § 352(a)(1)] because it contained monensin at a concentration above the level stated in the product labeling (feeding directions accompanying the feed), making the labeling false or misleading.

The introduction or delivery for introduction into interstate commerce of any food that is adulterated or misbranded is a prohibited act within the meaning of Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. 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. On April 27, 2021, you were issued an amended Form FDA 483. We acknowledge your written response dated May 12, 2021. We have reviewed your response and address your corrective actions below.

Current Good Manufacturing Practice (CGMP) Requirements For Medicated Feeds

As a non-licensed, medicated feed mill, your facility is subject to the medicated feed CGMP regulations for non-licensed, medicated animal feed manufacturers found in 21 CFR 225.120-225.202. During the inspection of your facility, an FDA Investigator observed evidence of significant violations of these requirements as indicated by the following:

1. You failed to ensure that the amount of the Type A medicated article of monensin added during the production of a Type C medicated feed for growing beef cattle on pasture or in a dry lot (stocker and feeder cattle and dairy and beef replacement heifers) was in accordance with the monensin’s labeled mixing directions as required by 21 CFR 225.142.

Specifically, your facility manufactured a custom formulated Type C medicated cattle feed between (b)(4) and (b)(4) that contained a super-potent concentration of monensin. On (b)(4), your facility received order number 483855 for 6 tons of medicated feed containing monensin. One of your employees created the formulation for order number 483855 to include 40.5 pounds (lbs) of Rumensin 90G in an approximate 6-ton lot (612 g/ton of monensin). On (b)(4), due to a mix-up at the (b)(4) station, an employee changed the order number to 483857 and manufactured an approximate 8-ton lot with 54.3 lbs of (b)(4), as a substitute for Rumensin 90G (616 g/ton of monensin). The maximum approved concentration of monensin in a cattle feed labeled for growing beef cattle on pasture or in a dry lot (stocker and feeder cattle and dairy and beef replacement heifers) for increased rate of weight gain is 400 g/ton as defined by
21 CFR 558.355(f)(3)(vi).

The super-potent cattle feed distributed under order number 483857 was reported to have contributed to the deaths of approximately eighty-seven (87) growing cattle following its consumption.

2. You failed to ensure that all deliveries of medicated feeds, whether bagged or in bulk, are adequately labeled to assure that the feed can be properly used as required by 21 CFR 225.180.

Specifically, on or after February 18, 2021, you distributed a Type C medicated feed under order number 483857 for growing beef cattle on pasture or in a dry lot (stocker and feeder cattle and dairy and beef replacement heifers) for increased rate of weight gain. The labeling provided with the delivery has feeding directions that state, “Feed 2.3 to 8.8 lbs/head/day to provide at a rate of 50 to 200 milligrams/head/day in not less than 1 pound of feed or, after the 5th day, feed at a rate of 400 milligrams/head/day every other day in not less than 2 pounds of feed.” However, this custom formulated Type C medicated feed contained monensin at a concentration of approximately 616 grams/ton. Therefore, when fed at a rate of 2.3 to 8.8 lbs/head/day, it would provide monensin at a rate of approximately 708 to 2,710 milligrams (mg)/head/day.

Misbranded Animal Food

During the inspection of your facility, an FDA Investigator reviewed the animal feed labeling for order number 483855/483857 and found evidence that the formulated product was misbranded under Section 502(a)(1) of the FD&C Act [21 U.S.C. § 352(a)(1)] because the labeling was false or misleading.

Specifically, order number 483855/483857 was custom formulated to contain monensin at a concentration of approximately 616 grams/ton. However, the labeling accompanying the animal feed stated that the monensin concentration was 45 grams/ton. Additionally, the feeding directions in the labeling state, “Feed 2.3 to 8.8 lbs/head/day to provide at a rate of 50 to 200 milligrams/head/day in not less than 1 pound of feed or, after the 5th day, feed at a rate of 400 milligrams/head/day every other day in not less than 2 pounds of feed,” which is inconsistent with the formulated concentration level. The manufactured feed containing approximately 616 grams/ton would provide approximately 308 mg/lb. This feed, when fed at a rate of 2.3 to 8.8 lbs/head/day, would provide monensin at a rate of approximately 708 to 2,710 mg/head/day, which is approximately 3.5 to 13.5 times the maximum labeled daily intake of 200 mg/head/day (or 400 mg/head every other day).

Corrective Actions

We have reviewed your May 12, 2021 response to the Form FDA 483 (Inspectional Observations). You reported that you have taken measures to educate employees on how to:

 place a label with the product and keep such label with the product until such time the product has been included in the feed ration,
 properly formulate feed rations,
 calculate the inclusion rate in the finished feed,
 ensure the inclusion rate, as well as the rate stated in the feeding directions, is in the approved range for the intended class of animal that is being fed,
 ensure the correct amount of medicated article and (b)(4) included in a feed ration are weighed correctly, and
 notify the office prior to delivery if the inclusion rate of a medicated article deviates from the stated value on the feed run sheet so that the feeding direction sheet can be corrected and checked to ensure the inclusion rate is in the approved range for the intended species.

However, we are unable to fully evaluate your corrective actions since you did not provide supporting documentation to demonstrate the promised corrections have been completed or implemented. We encourage you to submit supporting documentation related to your corrective actions in your reply.

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. Failure to adequately address this matter may lead to legal action, including without limitation, seizure, and injunction.

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 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.

Sincerely,
/S/

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