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WARNING LETTER 643463

February 10, 2023

Dear Mr. Emmons:

The U.S. Food and Drug Administration (FDA) conducted an inspection at your cattle dealing operation at 8331 Stonelick Road, Maysville, KY 41056 on August 17, September 7, and September 16, 2022. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that were revealed during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on the FDA’s webpage at www.fda.gov.External Link Disclaimer

As of the date on this letter, we have not received a response from you regarding items listed on your issued form FDA 483, Inspectional Observations.

Adulteration of an Animal Offered for Human Consumption

Our investigation found that you offered for sale an animal for slaughter as food that was adulterated¹. On December 8, 2021, you sold a cow identified with tag number (b)(4) and bangle tag number (b)(4) at a livestock auction in Owenton, KY. This cow (tag number (b)(4) and bangle tag number (b)(4)) was subsequently identified at the auction with back tag number (b)(4) and sale tag number (b)(4) and sold for slaughter as food. The animal was slaughtered on or about December 13, 2021, at FPL Food, LLC located in Augusta, GA. The United States Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) analysis of liver tissue samples collected from this animal identified the presence of florfenicol at a level of 6.70 parts per million (ppm) and tilmicosin at a level of 1.52 ppm. FDA has established a tolerance of 3.7 ppm for residues of florfenicol² in uncooked liver tissues and a tolerance of 1.2 ppm for tilmicosin³ in uncooked liver tissues of cattle. The presence of these drugs in edible tissue above tolerance levels causes the food to be adulterated¹. Furthermore, you did not inquire about the medication status of cattle that you transported, purchased and delivered for sale at an auction barn. The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act⁴.

Additionally, you caused the food to be adulterated because it was held under insanitary conditions whereby it may have been injurious to health.⁵ Our investigation found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Specifically, you did not clean water containers to prevent cross-contamination of medicated and non-medicated liquids. For instance, you stated that you add (b)(4) to water containers, but you do not flush or clean the container when the medicated water is consumed (or mostly consumed), and that the container remains in an area where healthy animals have access to it.

Furthermore, you did not maintain complete and accurate treatment records for your cattle that you medicate. For instance, your treatment records do not include tag numbers, dates of treatment, condition treated, dosage administered, or route of administration.

You also do not identify and segregate your treated cattle. You stated that your firm does not physically identify medicated animals and does not have a hospital pen for sick and medicated animals.

Further, we noted that you lack an adequate system to account for the drugs held for use in treating your food-producing animals. For example, the following expired drugs were observed on site, which could potentially be used to medicate your animals:

1) Three bottles of “(b)(4)” were observed in your drug inventory with an expiration date of March 2022.
2) One box of (b)(4)” with an expiration date of April 2022.
3) Six bottles of “(b)(4)” with an expiration of May 2021.

Adulteration of a New Animal Drug

Our investigation found that you use Increxxa ™ (tulathromycin, ANADA 200-666) to treat cattle contrary to its label instructions. This drug contains a cautionary statement: “Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.” The drug was prescribed to you, for your use. You stated, however, that you allow this drug to be used by other individuals, including your employees, on animals that are not owned by you and that are not part of your cattle operation. Your extra-label use of this drug- specifically, permitting its use on animals not owned by you was not by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship.⁶ This causes the drug to be adulterated⁷. The adulteration of any drug in interstate commerce is a prohibited act.⁸

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our findings 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.

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 action 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 you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.

Please send your firm’s response to Shondra N. Gipson, Compliance Officer, at ORAHAFEAST5FirmResponses@fda.hhs.gov. Alternatively, you may mail your response to Shondra N. Gipson, 404 BNA Drive, Suite 500, Nashville, TN 37217. If you have any questions about this letter, please contact Shondra N. Gipson at 615-366-7867.

Sincerely,
/S/

Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East 5

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1 Under section 402(a)(2)(C)(ii) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(ii)], a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe. Under section 512(a)(4)(B) of the FD&C Act [21 U.S.C. § 360b(a)(4)(B)], a drug is unsafe if it results in any residues that exceed any established safe levels.

2 See Title 21, Code of Federal Regulations 556.283(b)(1)(i) [21 CFR 556.283(b)(1)(i)]

3 See 21 CFR 556.735(b)(1)(i)

4 See section 301(a) of the FD&C Act [21 U.S.C § 331(a)].

5 See section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)]

6 See 21 CFR 530.11(a).

7 See section 501(a)(5) of the FD&C Act [21 U.S.C § 351(a)(5)].

8 See section 301(b) of the FD&C Act [21 U.S.C § 331(b)].