- Delivery Method:
- VIA UPS
- Animal & Veterinary
Recipient NameSteven R. Kanz
- Lewiston Feed & Produce Company
105 E. Main Street
Lewiston, MN 55952
- Issuing Office:
- Office of Human and Animal Foods – West Division
September 15, 2021
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.
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.
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.
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.
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.
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.
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).