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March 12, 2024

WARNING LETTER

Refer to CMS 668925

Dear Mr. Poeschl:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your non-FDA licensed medicated animal food manufacturing facility (feed mill), located at W9077 Schutz Road, Lodi, Wisconsin, from August 23 through 28, 2023. This inspection was initiated in response to a Reportable Food Registry (RFR) report involving multiple goat illnesses and deaths after the goats consumed medicated goat feed that contained monensin (Product B9251, 18% Goat Starter, lot number 071423) that was manufactured at your facility. On August 21, 2023, you initiated a voluntary Class I recall of this goat feed due to excessive monensin.

During the inspection the FDA investigator found evidence that you manufactured and distributed a goat feed, Product B9251, 18% Goat Starter, lot number 071423, that contained a super-potent concentration of the new animal drug monensin. This Type C medicated goat feed containing the Type A medicated article monensin is unsafe because the new animal drug was not used in conformance with the drug approval.¹ As a result, the goat feed containing the new animal drug is adulterated.²

In addition, the inspection revealed a significant violation 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 causes your products to be adulterated.³ Failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of 21 CFR Part 507 is a prohibited act.⁴

Furthermore, FDA’s investigator found evidence of a significant violation of the Current Good Manufacturing Practice (CGMP) for Medicated Feeds requirements, 21 CFR Part 225. Failure of your medicated feed mill to comply with these requirements causes your medicated feed to be adulterated.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 prohibited.⁶

You may find the FD&C Act and FDA’s regulations through links on FDA’s website 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 dated September 1 and 12, 2023, and address your corrective actions below.

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 observed evidence of a significant violation of these requirements:

1. You did not identify and implement a preventive control to provide assurance that any hazard requiring a preventive control will be significantly minimized or prevented, as required by 21 CFR 507.34(a)(1).

Specifically, your hazard analysis determined that monensin requires a preventive control to avoid the known hazard of “high medication in feed.” Your food safety plan identified a preventive control to be applied at the “(b)(4)” step. You identified this preventive control as “Process Control-(b)(4) Monensin 90 PC 001 Drug Receipt & Inventory (b)(4) Report of Monensin or Mill mix for minerals.” This preventive control requires a (b)(4) drug inventory reconciliation and a second reviewer signature on the (b)(4) report. Your preventive control has a “parameter” of a second sign-off being recorded on the (b)(4) Monensin 90 PC 001 Drug Receipt & Inventory and (b)(4) reports. Your second sign-off is not a parameter.⁷

This preventive control is inadequate. For example, on July 14, 2023, your employee added (b)(4) of monensin to lot 071423 of your Product B9251, 18% Goat Starter. However, this formulation of your 18% Goat Starter required only (b)(4) pounds of monensin and this error resulted in a super-potent monensin concentration of (b)(4) in the finished goat feed. This super-potent concentration was over (b)(4) times above the labeled monensin concentration of 20g/ton in the finished goat feed. You shipped the super-potent finished goat feed to four customers, who reported goat illnesses and deaths after their goats consumed the feed.

During your investigation into the cause of this error you determined your employee “grabbed the wrong raw material.” However, the Mill Mix Report called for Monovet 90 and your documents indicate your employees used Monovet 90.

Your investigation also determined that the “second signature [process] was not followed properly.” However, your documents show two employees initialed both the (b)(4) Monensin 90 PC 001 Drug Receipt & Inventory and the (b)(4) Report. Your (b)(4) Monensin 90 PC 001 Drug Receipt & Inventory tracks the medicated article removed and physically weighed out for each medicated production run. This is then compared to your actual drug inventory and recorded as the (b)(4) drug inventory. However, your preventive control does not ensure that the amount of drug pulled from inventory and the amount of drug added to the production batch are compared to the product’s intended formulation as noted on the (b)(4) Report.

We acknowledge your written responses to the FDA-483 and information you provided to the FDA investigator during the inspection that describe corrective actions you have taken or plan to take to address this observation, including employee retraining, revising your food safety plan by adding a comparison of your inventory with your electronic (b)(4) usage report, and conducting a (b)(4) physical inventory of drugs. Your responses did not include documentation of these corrective actions. Therefore, we are unable to fully evaluate them. More importantly, your corrections provided at the close of the inspection and in response to the FDA-483 continue to identify the second sign-off as your preventive control which, as stated above, is a demonstrably inadequate preventive control to ensure the amount of drug weighed and added to the batch matches the amount identified in the formulation.

Current Good Manufacturing Practice for Medicated Feeds Requirements

Your facility is required to follow the medicated feed CGMP regulations for non-licensed, medicated animal feed manufacturers found in 21 CFR 225.120–202. During the inspection of your facility the FDA investigator observed evidence of a significant violation of these requirements:

2. You did not establish and maintain adequate procedures for the identification, storage, and inventory control (receipt and use) of all Type A medicated articles and Type B medicated feeds intended for use in the manufacture of medicated feeds to aid in assuring the identity, strength, quality, and purity of these drug sources. All Type A medicated articles and Type B medicated feeds must be used in accordance with their labeled mixing directions, as required by 21 CFR 225.142.

Specifically, while the formula for your Product B9251, 18% Goat Starter, called for (b)(4) of monensin Type A medicated article (consistent with the labeled mixing directions), your records show that on July 14, 2023, your employee added (b)(4) of a monensin Type A medicated article to lot 071423 of your Product B9251, 18% Goat Starter.

A review of your F 789 Monensin 90 PC 001 Drug Receipt & Inventory Record Lot No VSB213 and your Production Run Summary Report 159067 for Formula (Product) B9251 produced on July 14, 2023, revealed that the records were not in agreement. Your F 789 Monensin 90 PC 001 Drug Receipt & Inventory Record Lot No VSB213 for the date of July 13, 2023, documents (b)(4) were pulled from inventory for a (b)(4) batch of Product B9251. Your Production Run Summary Report 159067 for Formula (Product) B9251 produced on July 14, 2023, documents that only (b)(4) were placed into the batch.

In addition, your F 789 Monensin 90 PC 001 Drug Receipt & Inventory Record Lot No VSB213 and your (b)(4) Report for Formula (Product) B9251 indicate the drug inventorying and the drug inclusion into production run 159067 were performed by the same individuals, neither of whom noted the amount pulled from the drug inventory exceeded the quantity required on the Hand ADD WEM Report. Your procedures indicate that an “Inventory Control Supervisor or SAP Support” will verify (b)(4) that there are two signatures on the (b)(4) Report. The (b)(4) Report for Formula (Product) B9251 dated July 13, 2023, was not signed and dated as being reviewed by an “Inventory Control Supervisor or SAP Support.” Furthermore, there was no documentation the records were verified by anyone for accuracy (theoretical usage based on formula versus actual medicated article pulled from inventory for production) prior to or following the distribution of Product B9251, 18% Goat Starter, lot 071423.

We acknowledge your verbal responses at the close of the inspection and your written responses to the FDA-483 that describe corrective actions you have taken or plan to take to address this observation, including employee retraining, conducting a (b)(4) physical inventory of drugs, and comparison of your inventory with your electronic (b)(4) usage report. However, a comparison of your daily inventory and the theoretical inventory along with a review and comparison with your production and your electronic (b)(4) usage report would not be adequate without a comparison to the formulas produced. Further, your response does not include supporting documentation to demonstrate your corrections have been completed and are consistently implemented. Therefore, we are unable to fully evaluate the adequacy of your response. We encourage you to provide documentation of your corrective actions in follow-up correspondence.

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.

We also have the following comments:

• Any preventive control that you establish is subject to preventive control management components, as required by 21 CFR 507.39. These management components include:
    o Monitoring in accordance with 21 CFR 507.40, which requires that you establish and implement written procedures for monitoring preventive controls, monitor the preventive controls with adequate frequency to provide assurance that they are consistently performed, and document the monitoring of preventive controls in records that are subject to verification that monitoring is being conducted,⁸ and records review.⁹
    o Corrective actions and corrections in accordance with 21 CFR 507.42, which require that you establish and implement written corrective action procedures that must be taken if preventive controls are not properly implemented; and
    o Verification in accordance with 21 CFR 507.45, which must include, as appropriate, verification that monitoring is being conducted, verification that appropriate decisions about corrective actions are being made, verification of implementation and effectiveness, and re-analysis of your food safety plan. Verification activities must be documented in records.
• 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 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 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 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 [email protected]. If you have questions regarding any issues in this letter, you may contact Compliance Officer Warren at (612) 758-7182.

Sincerely,
/S/

CAPT Greg Smith, PharmD
Acting Program Division Director, West Division 1
Office of Human and Animal Food Operations

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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 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).

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).

6 See Section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].

7 For a discussion of parameters in the context of process controls, see GFI #245, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, pp. 67-68, available at https://www.fda.gov/media/110477/download.

8 See 21 CFR 507.45(a)(2).

9 See 21 CFR 507.49(a) which says in part, “You must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing hazards. To do so, you must conduct activities that include the following . . . Review … by (or under the oversight of) a preventive controls qualified individual . . . [of m]onitoring and corrective action records within 7 working days after the records are created or within a reasonable timeframe . . ..”