WARNING LETTER

J.D. Heiskell Holdings LLC MARCS-CMS 700893 — June 12, 2025

Delivery Method:: VIA EMAIL WITH READ RECEIPT
Product:: Animal & Veterinary

Recipient:: Recipient Name

Bradley R. More; Recipient Title

Plant Manager; J.D. Heiskell Holdings LLC; 2407 Warren Ave
Twin Falls, ID 83301-7978
United States; (b)(6)

Issuing Office:: Center for Veterinary Medicine; United States

WARNING LETTER
CMS # 700893

June 12, 2025

Dear Bradley More,

The U.S. Food and Drug Administration (FDA) conducted an inspection of your unlicensed feed mill that manufactures both medicated and non-medicated animal food, located at 2407 Warren Avenue, Twin Falls, Idaho, from December 2 to 5, 2024. The inspection was initiated in response to a Reportable Food Registry (RFR) report your firm filed on November 11, 2024, after receiving a consumer complaint on October 20, 2024, reporting multiple deaths of calves after consuming your Bliss Calf Starter medicated feed product. Your third-party lab analyzed samples of feed from the customer and reported the presence of excessive monensin in one lot of Bliss Calf Starter. You initiated a voluntary Class I recall of this medicated feed due to excessive monensin on October 21, 2024. We received and evaluated your written response to the Form FDA 483, Inspectional Observations, (FDA 483) dated December 9, 2024.

During the inspection, the FDA investigator found evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements found in Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507) which causes your products to be adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.¹ In addition, 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 prohibited.²

In addition, the FDA investigator found evidence that you manufactured and distributed Bliss Calf Starter medicated 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 because the new animal drug was not used in conformance with the drug approval because the quantity in the final feed exceeded the approved safe level for use in cattle feed.³ As a result, the Bliss Calf Starter medicated feed containing the new animal drug is adulterated.⁴

Further, the inspection revealed evidence of significant violations of Current Good Manufacturing Practice (CGMP) for Medicated Feeds, 21 CFR Part 225. Failure of your medicated feed mill to comply with these requirements also causes your medicated and non-medicated feeds to be adulterated.⁵

Additionally, your Bliss Calf Starter feed is misbranded because its labeling does not bear adequate directions for use.⁶ As described further below, you attempted to recondition the Bliss Calf Starter medicated feed containing a super-potent concentration of monensin by mixing the feed into your non-medicated Dry Creek High Cow formulation. Therefore, your Dry Creek High Cow feed is also misbranded because its label does not bear the name and quantity of each active ingredient.⁷

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 article being adulterated or misbranded is prohibited.⁸

Furthermore, you failed to report a reportable food to the RFR within twenty-four hours of determining that it is a reportable food (i.e., an animal food for which there is a reasonable probability that the use of, or exposure to, such animal food will cause serious adverse health consequences or death to animals).⁹ Failure to submit a required reportable food report is a prohibited act.¹⁰

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 an FDA 483. As noted above, we received your written response dated December 9, 2024. We have reviewed your response and address your corrective actions below in relation to each of the noted violations.

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 significant violations of these requirements, which included the following:

1. You failed to sufficiently assess the probability that a hazard will occur in the absence of preventive controls, as required by 21 CFR 507.33(c)(1).

a. Your hazard analysis identified that excess animal drug due to “weighing error” is a known or reasonably foreseeable hazard, and you determined that a preventive control was not required due to your prerequisite program. Specifically, your hazard analysis indicates that you will control the hazard at the “(b)(4)” step through the use of “(b)(4) Procedure” and (b)(4) verification prerequisite programs.

However, your prerequisite program was not implemented in a way that reduces the probability of occurrence of the hazard, as evidenced by the excessive monensin in batch (b)(4) of your Bliss Calf Starter medicated feed. On October 13, 2024, your employee added 169.6 lbs. of monensin to this batch of Bliss Calf Starter medicated feed, which exceeds the (b)(4) lbs. of monensin that is called for in this formulation of feed and resulted in a calculated super-potent concentration of 476 g/ton in the finished calf feed. After a customer notified you of calf deaths after consuming the Bliss Calf Starter medicated feed, your facility collected and submitted samples of the feed to a third-party laboratory, which found that it contained 276 g/ton of monensin. Therefore, you did not reduce the probability that the excess animal drug hazard would occur in the absence of a preventive control.

Evaluation of your response:
During the inspection and in your written response dated December 9, 2024, you stated that you made corrections including verifying the drug log and monitoring the accuracy of (b)(4) adds (b)(4) and amending your “(b)(4) and (b)(4) SOP 208” procedure for drug quantities to be entered into your electronic usage report. However, we are unable to fully evaluate your corrective actions since you did not provide supporting documentation to demonstrate that these corrections have been implemented or that employees have been trained regarding the updated procedure. We encourage you to provide us with documentation of implementation of your corrections in follow-up correspondence.

b. Your hazard analysis identified at the “Rework & Returned Material” manufacturing step that you are controlling the “(b)(4)” hazard using your “Rework Plan” as a prerequisite program. However, you stated during the inspection that you did not have a rework written procedure. If you rely on a prerequisite program in your evaluation of the probability of occurrence of a hazard, adequate information about the prerequisite program must be included in your hazard analysis as part of your evaluation.

Furthermore, despite your claimed prerequisite program, you mixed the recalled Bliss Calf Starter medicated feed containing monensin with a non-medicated customer-formula animal food to produce a reworked product labeled Dry Creek High Cow which you estimated contained 9.66 g/ton of monensin. The Dry Creek High Cow food was not labeled to contain monensin. Therefore, your prerequisite program does not reduce the probability of the hazard of medication in a non-medicated animal food in the absence of a preventive control.

Evaluation of your response:
Your written response to the FDA 483 stated that you intend to establish a written standard operating procedure for reconditioning feed within the next 90 days, which will include a written rework plan and records that accurately document how feed is reconditioned. To date, we have not received a copy of the procedure or records to demonstrate your corrections have been implemented. Therefore, we are unable to fully evaluate your corrective actions. We encourage you to provide us with documentation of implementation of your corrections in follow-up correspondence.

c. Your reliance on prerequisite programs failed to reduce the probability that mycotoxins would occur in your animal food ingredients in the absence of a preventive control. Your hazard analysis identified mycotoxins, under “Natural toxins,” as a potential hazard for animal food ingredients including corn, soybeans, and wheat, and indicates that you will control the hazard with your preferred supplier program and “Quality Sample Schedule” prerequisite programs. However, our investigator found no evidence that you are following your prerequisite programs. For example, your sampling procedure states that each commodity will be tested for mycotoxins (b)(4). You were unable to provide any records to demonstrate that any of the ingredients susceptible to mycotoxins were sampled and analyzed for the presence of mycotoxins since March 2023.

Evaluation of your response:
Your response dated December 9, 2024, stated that your “Quality Sampling Schedule” procedure was not reflective of the actual sampling conducted at your establishment and that you will begin testing each commodity for mycotoxins (b)(4). However, you did not provide any documentation to demonstrate the implementation of your corrective actions. Furthermore, you did not provide any justification that (b)(4) analysis per commodity will be sufficient to control mycotoxins in the grain ingredients you use to manufacture animal food. Therefore, we are unable to fully evaluate the corrections you have made. We encourage you to provide us with documentation of implementation of your corrections in follow-up correspondence.

Medicated Feed Current Good Manufacturing Practice 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, the FDA investigator observed evidence of violations of these requirements, which included:

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 feed 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:

a. While your formula for Bliss Calf Starter medicated feed called for (b)(4) lbs. of monensin (consistent with the labeled mixing directions), your records show that on October 13, 2024, your employee added 169.6 lbs. of monensin to batch (b)(4) of your Bliss Calf Starter medicated feed.

Your “(b)(4) and (b)(4) SOP 208” was not adequate because it did not prevent the weighing error that resulted in a super-potent medicated feed that contained excessive monensin. Furthermore, you had no documentation that your drug log or batch records were verified by anyone for accuracy (theoretical usage based on formula versus actual medicated article pulled from inventory) prior to the distribution of your Bliss Calf Starter medicated feed, batch (b)(4).

b. During the inspection, you provided a reconditioning proposal, dated November 15, 2024, which documented your plan to manufacture Dry Creek High Cow animal food that is intended to be non-medicated. The proposal shows that the Dry Creek High Cow food would be combined with the recalled super-potent Bliss Calf Starter medicated feed, which you manufactured from the Type A medicated article monensin. This proposal does not document procedures for reworking medicated feed in a way that aids in assuring that Type A drug components maintain the identity, strength, quality, and purity throughout manufacturing at your facility and so that Type A medicated articles and Type B medicated feeds are used in accordance with their labeled mixing directions. Additionally, while you explained to the FDA investigator that the Dry Creek High Cow feed was manufactured in a (b)(4), this is not reflected in the reconditioning proposal.

Evaluation of your response:
In your written response dated December 9, 2024, you stated that your corrections included verifying the accuracy of the drug log (b)(4) and amending your “(b)(4) and (b)(4) SOP 208” procedure for drug quantities to be entered into your electronic usage report. You also stated that you intend to create a rework procedure and implementation records. However, your response did not include supporting documentation to demonstrate that these corrections have been implemented or that employees have been trained regarding the updated procedure. Therefore, we are unable to fully evaluate your corrections. We encourage you to provide us with documentation of implementation of your corrections in follow-up correspondence.

3. You failed to ensure that all deliveries of medicated feeds, whether bagged or in bulk, are adequately labeled to assure that the feed can properly be used, as required by 21 CFR 225.180.¹¹

Specifically, your Type C Bliss Calf Starter medicated feed label did not include adequate feeding directions set forth in the new animal drug approval for monensin-medicated cattle feed for the labeled monensin concentration of 60.9 g/ton, nor indications for use. Your label states, “Feed as directed by nutritionist.” We note that feeding directions and indications for use are sections included in the representative (“(b)(4)”) labeling for monensin-medicated cattle feed.¹²

Evaluation of your response:
In your written response dated December 9, 2024, you stated you intend to verify and update the necessary feed labels. However, you have not provided updated feed labels to demonstrate your corrections have been implemented. We are, therefore, unable to fully evaluate the corrections you have made.

Attempted Reconditioning of Adulterated Animal Food

In your reconditioning proposal, you documented that you attempted to recondition the Bliss Calf Starter feed, batch (b)(4), which contained a super-potent concentration of monensin (the “super-potent” feed), by mixing the super-potent feed with your standard-formulated Bliss Calf Starter feed, containing 60 g/ton monensin, to create an unspecified lot of Blended Bliss Calf Starter feed containing a calculated 154.6316 g/ton of monensin. You then mixed the Blended Bliss Calf Starter feed with non-medicated Dry Creek High Cow food to create at least (b)(4) lots containing a calculated 9.6644 g/ton of monensin. You labeled the finished product as Dry Creek High Cow, and its labeling did not declare monensin as an ingredient.

Therefore, you intentionally added the super-potent, adulterated medicated feed to a non-medicated animal food formulation. The deliberate mixing of adulterated food with good food renders the finished product adulterated, regardless of the final concentration of contaminant in the finished food.¹³ Therefore, your Dry Creek High Cow animal food is adulterated.¹⁴ 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 article being adulterated or misbranded is prohibited.¹⁵

Misbranded Animal Food

FDA reviewed your medicated feed and animal food labeling collected during the inspection and found evidence that some of your products were misbranded under the FD&C Act. Specifically:

4. According to your “Reconditioning Proposal,” you used the recalled medicated Bliss Calf Starter feed containing monensin and a non-medicated animal food to produce a medicated feed containing a calculated level of 9.66 g/ton of monensin. The resulting medicated animal feed, Dry Creek High Cow, bore a label that failed to declare the drug, monensin, and its quantity. The failure of your product’s label to declare the name and quantity of each active ingredient causes the product to be misbranded.¹⁶

5. As noted above, your label for the Type C Bliss Calf Starter medicated feed states, “Feed as directed by nutritionist.” This labeling does not conform to the approved representative (“(b)(4)”) labeling for monensin Type C medicated feed and does not bear adequate directions for use. Your label also does not include indications for use. Failure to bear adequate directions for use causes your Bliss Calf Starter medicated feed product to be misbranded.¹⁷

Reportable Food Registry (RFR)
You failed to report a reportable food to the RFR within 24 hours of determining that an article of food is reportable food (an article of food for which there is reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals), as required by section 417(d)(1) of the FD&C Act [21 U.S.C. § 350f(d)(1)].

Specifically, on October 20, 2024, you were informed by your customer of multiple calf deaths which occurred after the calves consumed your Bliss Calf Starter cattle medicated feed. You recalled this cattle feed between October 21-24, 2024, and sent samples of the feed to a third-party laboratory for analysis. On October 30, 2024, you received the third-party laboratory results that reported that the feed contained a super-potent concentration (276 g/ton) of monensin. However, you did not file the reportable food report until November 11, 2024.

The RFR was established to provide a reliable mechanism to track patterns of adulteration in food (including animal food) to support efforts by FDA to target limited inspection resources to protect public health. It requires a “responsible party” to file reportable food reports. The responsible party is the person who submits the registration under section 415 of the FD&C Act required for a food facility that is required to register, at which the reportable food was manufactured, processed, packed, or held.¹⁸ The responsible party is required to file a notification within 24 hours of determining that an article of food is a reportable food. Failure to submit a required reportable food report is a prohibited act under the FD&C Act.¹⁹

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 or regulatory action, including without limitation, seizure, and injunction.

For more information about the requirements of 21 CFR Part 507, 225, and 558, 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

• Medicated Feeds: https://www.fda.gov/animal-veterinary/animal-food-feeds/medicated-feeds

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 your products are not in violation of the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.

The Food & Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance is encouraging electronic submission of any response you choose to submit to this letter. We encourage you to submit files up to 100 megabytes in a single email, and to divide files greater than 100 megabytes so they may be submitted as smaller files in separate emails. If you submit electronic correspondence, please ensure that your facility’s name, the CMS number at the top of this letter, and the inspection location are included in your correspondence. We intend to issue an electronic acknowledgement upon receipt of your email.

Please direct your electronic correspondence to Compliance Officer Andrew Howard at Andrew.Howard@fda.hhs.gov.

If you have questions regarding this letter, please contact Compliance Officer Andrew Howard by telephone at (410) 779-5125, or by email at Andrew.Howard@fda.hhs.gov.

Sincerely,
/S/

Isaac K. Carney
Director of Food Compliance, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
U.S. Department of Health and Human Services

_____________________________

1 See Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(4)] and 21 CFR 507.1(a)(1)(ii).
2 See Section 301(uu) of the FD&C Act [21 U.S.C. § 342(uu)].
3 See Section 512(a)(2)(A)(i) of the FD&C Act [21 U.S.C. § 360b(a)(2)(A)(i)].
4 See Section 501(a)(6) of the FD&C Act [21 U.S.C. § 351(a)(6)].
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 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)].
7 See Section 502(e)(1)(A)(ii) of the FD&C Act [21 U.S.C. § 352(e)(1)(A)(ii)].
8 See Section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].
9 See Section 417(d) of the FD&C Act [21 U.S.C. § 350f(d)].
10 See Section 301(mm) of the FD&C Act [21 U.S.C. § 331(mm)].
11 See also 21 CFR 507.27(b).
12 See 21 CFR 558.355 and https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadBBL/3765.
13 See Compliance Policy Guide Sec 555.200 Adulterated Food Mixed with Good Food, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-555200-adulterated-food-mixed-good-food.
14 See Section 402(a)(2)(C)(ii) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(ii)].
15 See Section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].
16 See section 502(e)(1)(A)(ii) of the FD&C Act [21 U.S.C. § 352(e)(1)(A)(ii)].
17 See section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)].
18 See Sections 415 and 417(a)(1) of the FD&C Act [21 U.S.C. §§ 350d and 350f(a)(1)].
19 See Section 301(mm) of the FD&C Act [21 U.S.C. § 331(mm)].