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November 7, 2022

In reply, refer to CMS 638704

WARNING LETTER

Dear Mr. Young:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your licensed medicated feed manufacturing facility located at 343 North Highway 24, Rupert, Idaho on June 13-17, 2022, and June 27, 2022. Our inspection revealed evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF) regulation, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507) which cause your products to be adulterated.¹ 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 a prohibited act.² Also, the failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provision of 21 CFR Part 507 (located in subparts A, C, D, E, and F of Part 507) is also a prohibited act.³

In addition, the inspection revealed evidence of significant violations from the Current Good Manufacturing Practice for Medicated Feeds regulations, 21 CFR Part 225, which cause your medicated feeds to be adulterated.⁴

The inspection also revealed evidence of significant violations of the requirements for animal feed containing a veterinary feed directive (VFD) drug (VFD feed), 21 CFR Part 558.6, New Animal Drugs for Use in Animal Feeds. Failure of a facility to comply with the VFD requirements causes the resulting VFD feed to be unsafe within the meaning of the FD&C Act.⁵ A drug is adulterated if it is an animal feed bearing or containing a new animal drug and the animal feed is unsafe.⁶ Furthermore, the failure of a facility to follow the VFD requirements causes the VFD feed containing a VFD drug to no longer be exempt from the requirements that its labeling bear adequate directions for use and as a result, the drug is misbranded under the FD&C Act if it does not bear adequate directions for use.⁷

In addition, if a medicated feed mill is required to obtain a feed mill license, that facility is also required to register as a drug establishment on an annual basis. Failure of a licensed medicated feed mill to register under Section 510 of the FD&C Act causes the animal feed manufactured in that facility to be misbranded.⁸ You are a licensed medicated feed mill and as of the date of this letter your facility does not have a current drug registration.

You may find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). We have not received a response to the FDA 483 as of the date on this letter.

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 Investigators observed evidence of a significant violation of these requirements, which included:

1. You did not prepare, or have prepared, and did not implement a written food safety plan, as required by 21 CFR 507.31(a).

The preparation of the food safety plan must be overseen by your preventive controls qualified individual (PCQI) and must include the following:

a) The written hazard analysis as required by 21 CFR 507.33(a)(2).
b) The written preventive controls as required by 21 CFR 507.34(b).
c) The written supply-chain program as required by subpart E of 21 CFR Part 507.
d) The written recall plan as required by 21 CFR 507.38(a)(1).
e) The written procedures for monitoring the implementation of the preventive controls as required by 21 CFR 507.40(a).
f) The written corrective action procedures as required by 21 CFR 507.42(a)(1).
g) The written verification procedures as required by 21 CFR 507.49(b).

Specifically, you told FDA investigators that you were working on a food safety plan, but it has not been completed or signed. You provided an undated, in-progress food safety plan and your consultant stated that hazards are still being identified to determine which hazards might require a preventive control.

Additionally, at the close of the inspection you did not provide a timeline for completion and implementation of a food safety plan.

Current Good Manufacturing Practice (CGMP) Requirements

Your animal food facility is subject to the CGMP requirements found in 21 CFR Part 507, subparts A, B, and F. During the inspection of your facility, FDA Investigators observed evidence of a significant violation of these requirements, which included:

2. Your firm failed to evaluate raw materials and other ingredients susceptible to contamination with mycotoxins or other natural toxins, as required by 21 CFR 507.25(b)(2).

Specifically, you do not have procedures or conduct testing to determine whether mycotoxins, such as aflatoxin, fumonisin, or deoxynivalenol (DON), are present in the ingredients you receive, store, and use in your animal food. During the inspection, you stated you do not evaluate incoming ingredients or finished product for mycotoxins. Grain and grain co-products used as components in cattle and swine food at your facility including, but not limited to, corn and dried distiller’s grains are susceptible to mycotoxin contamination.

Veterinary Feed Directive (VFD) Requirements

Your animal food facility is subject to the VFD requirements found in 21 CFR 558.6. During the inspection of your facility, FDA Investigators observed evidence of a significant violation of these requirements, which include:

3. You manufactured and distributed an animal feed containing the VFD drug, Oxytetracycline, that did not comply with the terms of the VFD received for such drug, as required by 21 CFR 558.6(c)(2).

Specifically, you manufactured (b)(4) batches of (b)(4) which had a super potent concentration of (b)(4) Oxytetracycline that was delivered to your customer on January 12, 2022, (Blend Ticket (b)(4)), and May 26, 2022, (Blend Ticket (b)(4)). The drug concentration stated on the product labeling was listed as (b)(4) Oxytetracycline for these (b)(4) batches, neither of which conform to the VFD. The VFD, dated December 4, 2021, was for a concentration of 10 g/ton Terramycin 100MR (Oxytetracycline).

At the close of the inspection, you provided a revised label and Formulation Mix Report for (b)(4). The corrected label states a drug concentration of 10 g/ton. However, the formula you provided continues to contain (b)(4) Oxytetracycline rather than 10 g/ton Oxytetracycline as specified in the VFD. Therefore, your correction does not satisfy the requirement in 21 CFR 558.6(c)(2) that animal feed containing a VFD drug comply with the terms of the VFD.

Current Good Manufacturing Practice for Medicated Feeds Requirements

As a manufacturer of medicated feed for which an approved medicated feed license is required, your facility is subject to the CGMP for Medicated Feeds requirements found in 21 CFR 225.10 – 225.115. During the inspection of your facility, FDA investigators observed evidence of significant violations of these requirements, which included:

4. Your production records are not complete in that they did not include all the information required by 21 CFR 225.102(b)(2).

Specifically, your Blend Tickets, which are your production records for medicated feeds, were incomplete in that they did not contain the following: date of production, quantity of each drug component used, the actual quantity of medicated feed produced, or the written endorsement by a responsible individual in the form of a signature or initials.

5. You failed to maintain on the premises the original or copy of a record of each oral or written complaint received relating to the safety and effectiveness of the medicated feed that you produced, as required by 21 CFR 225.115(b)(1).

Specifically, you do not maintain written records of complaints that are received by telephone and by customers communicating directly with their sales representatives. For each oral and written complaint, you are required to document the following:

• Date of the complaint
• The complainant’s name and address
• Name and lot or control number or date of manufacture of the medicated feed involved
• The specific details of the complaint

Your complaint records also must include all correspondence from the complainant and/or memoranda of conversations with the complainant, and a description of all investigations made by the manufacturer and of the method of disposition of the complaint.

Misbranding

6. During the inspection of your facility, FDA Investigators found you failed to comply with the terms of the VFD for (b)(4) dated December 4, 2021, for 10 g/ton Oxytetracycline, as required by 21 CFR 558.6(c)(2). Failure to follow the VFD requirements causes the VFD feed to no longer be exempt from the requirements that its labeling bear adequate directions for use.⁹ The label you provided with the (b)(4) VFD feed does not bear adequate directions for use because it failed to include duration of administration and preparation for use (i.e., dilution)¹⁰, therefore, the VFD drug is misbranded.¹¹

7. During the inspection of your facility, an FDA Investigator reviewed the animal feed labeling for Blend Tickets (b)(4) and (b)(4) and found evidence that the formulated product was misbranded because the labeling was false or misleading.¹²

Specifically, Blend Tickets (b)(4) and (b)(4) were custom formulated to contain Oxytetracycline at a concentration of approximately (b)(4). However, the labeling accompanying the animal feed stated that the Oxytetracycline concentration was (b)(4). This formulated concentration is approximately (b)(4) more Oxytetracycline than the labeled concentration.

Conclusion

This letter is not intended to be an all-inclusive statement of violations that 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, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

We also have the following comment:

During the inspection, our investigators also observed additional concerning CGMP conditions in your facility involving maintenance of your plant and grounds as well as sanitation of your facilities, equipment, and utensils. These conditions include:

a. Build-up of unknown debris on animal food contact surfaces including your mixer in the bulk mixing plant and in the bed of a truck used to transport bulk feed. [21 CFR 507.22(a)(4)(iii)]
b. Residual product and/or dust was observed in the air and settling on surfaces including the mixer and bagging equipment. [21 CFR 507.19(a)]
c. Exposed insulation hanging from the ceiling and walls above and adjacent to bulk, uncovered ingredients. [21 CFR 507.19(a)]
d. Birds were observed landing and feeding on bulk ground corn and bird feces was observed on exposed blood meal. [21 CFR 507.17(c)]

It is important to maintain your facility and animal food contact surfaces in a state where animal food products do not become contaminated or adulterated.

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

For more information about chemical hazards, including mycotoxins, see:

• “Chemical Hazards” https://www.fda.gov/animal-veterinary/biological-chemical-and-physicalcontaminants-animal-food/chemical-hazards

For more information about FDA’s current thinking on the requirements relating to Veterinary Feed Directive Regulations, see:

• Draft Guidance for Industry #120: “Veterinary Feed Directive Regulation Questions and Answers (Revised)” https://www.fda.gov/media/70173/download

Please notify FDA in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to address these 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 frame within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.

Please send your response to the Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington, 98021, to the attention of Mark Babbitt, Compliance Officer. If you have any questions concerning this letter, you can contact Mr. Babbitt at (509) 353-2136 ext. 107, or via email at mark.babbitt@fda.hhs.gov.

Sincerely,
/S/

Miriam R. Burbach
Program Division Director
Office of Human and Animal Food Operations
West – Division 6

cc: Garth L. Searle, Livestock Division Manager
Land View, Inc.
P.O. Box 475
Rupert, Idaho 83350

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

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

4 See Section 501(a)(2)(b) of the FD&C Act [21 U.S.C. § 351(a)(2)(B)] and 21 CFR Part 225.1(b)(1).

5 See section 512(a)(2) of the FD&C Act [21 U.S.C. § 360b(a)(2)]

6 See section 501(a)(6) of the FD&C Act [21 U.S.C. § 351(a)(6)].

7 See Section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]; see also section 504(a)(1) of the FD&C Act [21 U.S.C. § 354(a)(1)].

8 See Section 502(o) of the FD&C Act [21 U.S.C. § 352(o)]

9 See section 504(a)(1) of the FD&C Act [21 U.S.C. § 354(a)(1)].

10 See 21 CFR 201.5

11 See Section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]

12 See section 502(a)(1) of the FD&C Act [21 U.S.C. § 352(a)(1)]