Bartlett Cooperative Association Bartlett Feed Mill of Bartlett, Kansas - inspection was conducted after a 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
- 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)].
- 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.
Lewiston Feed and Produce Company of, Lewiston, Minnesota, was inspected in response regarding elevated levels of monensin in the customer-formula medicated feed “(b)(4),” batch code 619202. Our inspection found that you adulterated this medicated animal feed in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
- based on the level of monensin in the medicated feed manufactured, the company actually manufactured a Type B medicated feed, rather than a Type C feed. Monensin is approved for use in Type B medicated animal feed at 41 to 80,000 grams per ton2 for the intended indications. A Type B medicated feed is intended for further manufacture, 21 CFR 558.3(b)(3). The label of your medicated feed did not include any mixing instructions. Failure to label a medicated animal feed with adequate directions for use results in that product being misbranded.2
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bartlett-cooperative-association-bartlett-feed-mill-614832-10202021
Bartlett Cooperative Association Bartlett Feed Mill
MARCS-CMS 614832 — OCTOBER 20, 2021
Product: Animal & Veterinary Drugs
Recipient:
Samuel Perry Sorrell
General Manager
Bartlett Cooperative Association Bartlett Feed Mill
401 Main St Ste A
Bartlett, KS 67332-3205
United States
Issuing Office:
Office of Human and Animal Foods West Division II
United States
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.External Link Disclaimer
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
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lewiston-feed-produce-company-613123-09152021
Lewiston Feed & Produce Company
MARCS-CMS 613123 — SEPTEMBER 15, 2021
Product: Animal & Veterinary Drugs
Recipient:
Samuel Perry Sorrell
General Manager
Bartlett Cooperative Association Bartlett Feed Mill
401 Main St Ste A
Bartlett, KS 67332-3205
United States
Issuing Office:
Office of Human and Animal Foods West Division II
United States
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.External Link Disclaimer
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
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lewiston-feed-produce-company-613123-09152021
Lewiston Feed & Produce Company
MARCS-CMS 613123 — SEPTEMBER 15, 2021
Product: Animal & Veterinary Drugs
Recipient:
Steven R. Kanz
President
Lewiston Feed & Produce Company
105 E. Main Street
Lewiston, MN 55952
United States
Issuing Office:
Office of Human and Animal Foods – West Division
United States
September 15, 2021
WARNING LETTER
Refer to CMS 613123
Dear Mr. Kanz:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your firm, Lewiston Feed and Produce Company, located at 105 E. Main Street, Lewiston, Minnesota, on December 16-17, 2020. This inspection was conducted in response (b)(3)(A) regarding elevated levels of monensin in the customer-formula medicated feed “(b)(4),” batch code 619202. Our inspection found that you adulterated this medicated animal feed in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
This medicated feed was manufactured on (b)(4), and delivered to a farm in (b)(4). On (b)(6), the farm’s veterinarian was called out to the farm to examine (b)(6) dead calves out of a herd of (b)(4) animals. Necropsies were conducted on two of the dead calves and tissue samples were submitted to the (b)(4) Diagnostic Laboratory for analysis. The veterinarian returned to the farm on (b)(6), after (b)(6) additional calves had died. Five more calves were necropsied and these additional tissue samples, as well as a feed sample, were submitted to the (b)(4) Diagnostic Laboratory for analysis. Based on the necropsy and histopathology findings as well as the finding of 296 grams/ton of monensin in the feed sample submitted to the diagnostic lab, the evidence indicates that the calves died from monensin toxicity.
Your firm was manufacturing this medicated product under an agreement with (b)(4) of (b)(4) supplied you with the formula for this customer’s feed. The feed’s labeling indicated that “(b)(4)” medicated feed, batch code 619202, was intended to be provided to cattle fed in confinement for slaughter “for the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii at a use level of 0.14 - 0.42 mg/lb body weight per day up to 480 mg/head/day, depending on the severity of challenge.” During our inspection you provided a copy of the formulation for this medicated feed, showing that it had been formulated and was then manufactured by you to contain 453.5 grams per ton of monensin. The customer fed this product to their cattle without dilution, using their normal feeding practices, and by (b)(6) of (b)(6) calves had died.
A Type C medicated feed is intended as a complete feed for an animal and need not be further diluted, Title 21, Code of Federal Regulations, Part 558.3(b)(4), (21 CFR 558.3(b)(4)). Monensin is approved for this use in Type C medicated animal food at 10 to 40 grams per ton, 21 CFR 558.355(f)(3)(ii). “(b)(4)” batch code 619202 contained more than ten times the amount of monensin approved under the regulation for a Type C feed for the labeled indications, thus making the product superpotent and therefore adulterated.1
We note that, based on the level of monensin in the medicated feed you manufactured, you actually manufactured a Type B medicated feed, rather than a Type C feed. Monensin is approved for use in Type B medicated animal feed at 41 to 80,000 grams per ton2 for the intended indications. A Type B medicated feed is intended for further manufacture, 21 CFR 558.3(b)(3). The label of your medicated feed did not include any mixing instructions. Failure to label a medicated animal feed with adequate directions for use results in that product being misbranded.2
You may find the Act and FDA’s regulations through links on the FDA’s website at www.fda.gov.External Link Disclaimer
Medicated Feed Current Good Manufacturing Practice Requirements
Our inspection also documented significant violations of the Current Good Manufacturing Practice (CGMP) for Medicated Feeds regulations at 21 CFR Part 225. Failure to follow these requirements causes medicated animal feed to be adulterated under section 501(a)(2)(b) of the Act, 21 U.S.C. § 351(a)(2)(B). Additionally, (b)(3)(A).3
As a manufacturer of medicated feed for which an approved medicated feed license is required, your facility is subject to the CGMP requirements for medicated animal feeds found in 21 CFR 225.1 – 225.115. During the inspection of your facility, FDA investigators found evidence of the following violations:
1. Your firm did not have, and failed to develop, a complete master record file for the customer-formula medicated feed “(b)(4),” as required by 21 CFR 225.102(b)(1). Under this regulation, the firm is required to keep a copy of the correct formula, instructions for manufacturing, and a copy of the labeling to be used on the finished product, among other required information.
Specifically, although the nutritionist from (b)(4) provided the formula for this product, (b)(4) did not supply a label for you to attach to the finished feed prior to delivery to the customer, and you told our investigators that you did not go through your regular process of reviewing the formula and developing an appropriate label. If this label had been on file, the process of reviewing the formula and developing a label should have identified the formulation error that led to manufacture of the adulterated feed.
2. Your firm failed to label the customer-formula medicated feed “(b)(4)” with labeling providing directions for use which, if adhered to, will assure that the article is safe and effective for its intended purposes, as required by 21 CFR 225.80(a).
Specifically, the label you sent to the client appears to be a photocopied page of the Feed Additive Compendium, upon which you stamped the name and address of your company, added a box where you can write the grams per ton drug level, and you circled the intended indication for use. Although the page does contain the required caution and warning statements, there are no instructions explaining how to use the product, such as how much to feed each animal per day (for a Type C medicated feed) or how to mix it on the farm to achieve the intended (approved) potency (for a Type B medicated feed).
We note that 21 CFR 507.27(b) – part of the Current Good Manufacturing, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation – also requires the labeling of animal food ready for distribution to contain instructions for safely using the animal food for the intended species.
(b)(3)(A).4
Specifically, on July 15, 2020, you were informed that your product “(b)(4),” batch code 619202, had been implicated in the death of (b)(6) of about (b)(4) calves to which it had been fed. An investigation into the cause of death was initiated, and on July 20, 2020, the (b)(4) nutritionist confirmed that the feed that was fed to the calves contained a formulation error which caused the levels of monensin in the feed to be 453.5 grams per ton, ten times the intended level, as discussed above. (b)(3)(A), after being advised to do so by an inspector with the Minnesota Department of Agriculture.
(b)(3)(A).5, 6
Corrective Actions
You recalled “(b)(4),” batch code 619202, on July 15, 2020, notifying the agency of this recall on August 27, 2020. You indicated that the remainder of this lot of medicated feed had been spread on fields by the sole customer.
At the close of our inspection you were issued a Form FDA-483, Inspectional Observations. To date, the agency has not received any written response from your firm regarding the observations noted on the Form FDA-483. During the close-out meeting your firm verbally discussed with the investigators that you would be implementing a new software program called “(b)(4),” which would send an alert to the operator if you were trying to make a medicated feed that was out-of-specification of the regulatory requirements.
Conclusion
This letter is not intended to be an all-inclusive list 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 you comply 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 or regulatory action, including without limitation, seizure, and injunction.
(b)(3)(A)
For your information, during the new animal drug approval process drug sponsors develop template labels for every approved use. Over time, these templates have come to be known as “Blue Bird Labels.” These Blue Bird Labels are intended to be made available to each sponsor’s customers, to help them properly label the finished medicated feeds being manufactured. Copies of the Blue Bird Labels can be obtained from the drug sponsor, and FDA also maintains a website where they can be found and copied. A copy of the approved Blue Bird Label for the Type C medicated feed for this intended use (“for the prevention and control of coccidiosis…”) can be found here: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadBBL/3105
A copy of the approved Blue Bird Label for the Type B medicated feed for this intended use (“for the prevention and control of coccidiosis…”) can be found here: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadBBL/3038
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps 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 action within 15 working days, state the reason for the delay and the time frame within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your written response to Carolyn A. Warren, Compliance Officer, U.S. Food and Drug Administration, at 250 Marquette Ave, Suite 600, Minneapolis, MN 55401, or email to Carolyn.Warren@fda.hhs.gov. If you have questions regarding any issues in this letter, you may contact Compliance Officer Warren at (612) 758-7182.
Sincerely,
/S/
Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Foods
________________________________
1 Sections 501(a)(6) and 512(a)(1)(A) of the Act, 21 U.S.C. §§ 351(a)(6) and 360b(a)(1)(A).
2 A medicated feed containing a new animal drug that is not labeled with adequate directions for use is misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).
3 (b)(3)(A).
4 (b)(3)(A).
5 (b)(3)(A).
6 (b)(3)(A).
Steven R. Kanz
President
Lewiston Feed & Produce Company
105 E. Main Street
Lewiston, MN 55952
United States
Issuing Office:
Office of Human and Animal Foods – West Division
United States
September 15, 2021
WARNING LETTER
Refer to CMS 613123
Dear Mr. Kanz:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your firm, Lewiston Feed and Produce Company, located at 105 E. Main Street, Lewiston, Minnesota, on December 16-17, 2020. This inspection was conducted in response (b)(3)(A) regarding elevated levels of monensin in the customer-formula medicated feed “(b)(4),” batch code 619202. Our inspection found that you adulterated this medicated animal feed in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
This medicated feed was manufactured on (b)(4), and delivered to a farm in (b)(4). On (b)(6), the farm’s veterinarian was called out to the farm to examine (b)(6) dead calves out of a herd of (b)(4) animals. Necropsies were conducted on two of the dead calves and tissue samples were submitted to the (b)(4) Diagnostic Laboratory for analysis. The veterinarian returned to the farm on (b)(6), after (b)(6) additional calves had died. Five more calves were necropsied and these additional tissue samples, as well as a feed sample, were submitted to the (b)(4) Diagnostic Laboratory for analysis. Based on the necropsy and histopathology findings as well as the finding of 296 grams/ton of monensin in the feed sample submitted to the diagnostic lab, the evidence indicates that the calves died from monensin toxicity.
Your firm was manufacturing this medicated product under an agreement with (b)(4) of (b)(4) supplied you with the formula for this customer’s feed. The feed’s labeling indicated that “(b)(4)” medicated feed, batch code 619202, was intended to be provided to cattle fed in confinement for slaughter “for the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii at a use level of 0.14 - 0.42 mg/lb body weight per day up to 480 mg/head/day, depending on the severity of challenge.” During our inspection you provided a copy of the formulation for this medicated feed, showing that it had been formulated and was then manufactured by you to contain 453.5 grams per ton of monensin. The customer fed this product to their cattle without dilution, using their normal feeding practices, and by (b)(6) of (b)(6) calves had died.
A Type C medicated feed is intended as a complete feed for an animal and need not be further diluted, Title 21, Code of Federal Regulations, Part 558.3(b)(4), (21 CFR 558.3(b)(4)). Monensin is approved for this use in Type C medicated animal food at 10 to 40 grams per ton, 21 CFR 558.355(f)(3)(ii). “(b)(4)” batch code 619202 contained more than ten times the amount of monensin approved under the regulation for a Type C feed for the labeled indications, thus making the product superpotent and therefore adulterated.1
We note that, based on the level of monensin in the medicated feed you manufactured, you actually manufactured a Type B medicated feed, rather than a Type C feed. Monensin is approved for use in Type B medicated animal feed at 41 to 80,000 grams per ton2 for the intended indications. A Type B medicated feed is intended for further manufacture, 21 CFR 558.3(b)(3). The label of your medicated feed did not include any mixing instructions. Failure to label a medicated animal feed with adequate directions for use results in that product being misbranded.2
You may find the Act and FDA’s regulations through links on the FDA’s website at www.fda.gov.External Link Disclaimer
Medicated Feed Current Good Manufacturing Practice Requirements
Our inspection also documented significant violations of the Current Good Manufacturing Practice (CGMP) for Medicated Feeds regulations at 21 CFR Part 225. Failure to follow these requirements causes medicated animal feed to be adulterated under section 501(a)(2)(b) of the Act, 21 U.S.C. § 351(a)(2)(B). Additionally, (b)(3)(A).3
As a manufacturer of medicated feed for which an approved medicated feed license is required, your facility is subject to the CGMP requirements for medicated animal feeds found in 21 CFR 225.1 – 225.115. During the inspection of your facility, FDA investigators found evidence of the following violations:
1. Your firm did not have, and failed to develop, a complete master record file for the customer-formula medicated feed “(b)(4),” as required by 21 CFR 225.102(b)(1). Under this regulation, the firm is required to keep a copy of the correct formula, instructions for manufacturing, and a copy of the labeling to be used on the finished product, among other required information.
Specifically, although the nutritionist from (b)(4) provided the formula for this product, (b)(4) did not supply a label for you to attach to the finished feed prior to delivery to the customer, and you told our investigators that you did not go through your regular process of reviewing the formula and developing an appropriate label. If this label had been on file, the process of reviewing the formula and developing a label should have identified the formulation error that led to manufacture of the adulterated feed.
2. Your firm failed to label the customer-formula medicated feed “(b)(4)” with labeling providing directions for use which, if adhered to, will assure that the article is safe and effective for its intended purposes, as required by 21 CFR 225.80(a).
Specifically, the label you sent to the client appears to be a photocopied page of the Feed Additive Compendium, upon which you stamped the name and address of your company, added a box where you can write the grams per ton drug level, and you circled the intended indication for use. Although the page does contain the required caution and warning statements, there are no instructions explaining how to use the product, such as how much to feed each animal per day (for a Type C medicated feed) or how to mix it on the farm to achieve the intended (approved) potency (for a Type B medicated feed).
We note that 21 CFR 507.27(b) – part of the Current Good Manufacturing, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation – also requires the labeling of animal food ready for distribution to contain instructions for safely using the animal food for the intended species.
(b)(3)(A).4
Specifically, on July 15, 2020, you were informed that your product “(b)(4),” batch code 619202, had been implicated in the death of (b)(6) of about (b)(4) calves to which it had been fed. An investigation into the cause of death was initiated, and on July 20, 2020, the (b)(4) nutritionist confirmed that the feed that was fed to the calves contained a formulation error which caused the levels of monensin in the feed to be 453.5 grams per ton, ten times the intended level, as discussed above. (b)(3)(A), after being advised to do so by an inspector with the Minnesota Department of Agriculture.
(b)(3)(A).5, 6
Corrective Actions
You recalled “(b)(4),” batch code 619202, on July 15, 2020, notifying the agency of this recall on August 27, 2020. You indicated that the remainder of this lot of medicated feed had been spread on fields by the sole customer.
At the close of our inspection you were issued a Form FDA-483, Inspectional Observations. To date, the agency has not received any written response from your firm regarding the observations noted on the Form FDA-483. During the close-out meeting your firm verbally discussed with the investigators that you would be implementing a new software program called “(b)(4),” which would send an alert to the operator if you were trying to make a medicated feed that was out-of-specification of the regulatory requirements.
Conclusion
This letter is not intended to be an all-inclusive list 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 you comply 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 or regulatory action, including without limitation, seizure, and injunction.
(b)(3)(A)
For your information, during the new animal drug approval process drug sponsors develop template labels for every approved use. Over time, these templates have come to be known as “Blue Bird Labels.” These Blue Bird Labels are intended to be made available to each sponsor’s customers, to help them properly label the finished medicated feeds being manufactured. Copies of the Blue Bird Labels can be obtained from the drug sponsor, and FDA also maintains a website where they can be found and copied. A copy of the approved Blue Bird Label for the Type C medicated feed for this intended use (“for the prevention and control of coccidiosis…”) can be found here: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadBBL/3105
A copy of the approved Blue Bird Label for the Type B medicated feed for this intended use (“for the prevention and control of coccidiosis…”) can be found here: https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadBBL/3038
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps 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 action within 15 working days, state the reason for the delay and the time frame within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your written response to Carolyn A. Warren, Compliance Officer, U.S. Food and Drug Administration, at 250 Marquette Ave, Suite 600, Minneapolis, MN 55401, or email to Carolyn.Warren@fda.hhs.gov. If you have questions regarding any issues in this letter, you may contact Compliance Officer Warren at (612) 758-7182.
Sincerely,
/S/
Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Foods
________________________________
1 Sections 501(a)(6) and 512(a)(1)(A) of the Act, 21 U.S.C. §§ 351(a)(6) and 360b(a)(1)(A).
2 A medicated feed containing a new animal drug that is not labeled with adequate directions for use is misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).
3 (b)(3)(A).
4 (b)(3)(A).
5 (b)(3)(A).
6 (b)(3)(A).
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