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WARNING LETTER

January 29, 2020

Refer to CMS 596961

FEI: 3015636426

Dear Mr. Smith

On October 10 and October 21, 2019, the United States Food and Drug Administration (FDA) conducted an inspection of your cattle farm operation, known as Brad D. Smith Farm, located at 3741 220th St., Estherville, IA. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the 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 web page at www.fda.gov.

Adulteration of an Animal Offered for Human Consumption:
We found that you offered for sale an animal for slaughter as food that was adulterated. 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 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on May 28, 2019, you sold a cow identified with ear tag number (b)(4) for slaughter as food. On May 31, 2019 (b)(4), slaughtered this animal. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of Florfenicol at 0.33 ppm in the muscle tissue.

FDA has established a tolerance of 0.3 ppm for residues of Florfenicol in uncooked edible muscle tissues of cattle as codified in Title 21, Code of Federal Regulations (CFR), section 556.283(b)(1)(ii) (21 C.F.R. § 556.283). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).

Additionally, the United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal also identified the presence of (b)(4) in the kidney tissue. FDA has not established a tolerance for (b)(4) in uncooked edible tissues of cattle. The presence of this drug in edible tissue from this animal in any amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).

Our investigation also 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. You lack an adequate system to ensure that medicated animals have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, in your signed affidavit, you indicated that you discarded the Discharge Instructions from the (b)(4) which showed the pre-slaughter withdrawal periods for (b)(4) and did not incorporate this information into on-farm records for cow number (b)(4). In addition, you failed to maintain complete and accurate treatment records. Your records did not include the condition being treated, dosage, route of administration, the person who administered treatment, and meat/milk withdrawal times. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).

Adulteration of a New Animal Drug
We also found that you adulterated the (b)(4) animal drug (b)(4)) and the human drug, (b)(4). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling or under the conditions of 21 C.F.R. § 530 Use of these drugs in this manner is an extra-label use, as defined by 21 C.F.R. § 530.3(a). The extra label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 CFR Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship as defined by 21 C.F.R. § 530.3(i)(1).

Our investigation found that your veterinarian administered (b)(4) on 5/22/2019 to the beef cow identified with ear tag number (b)(4) and advised you to observe a (b)(4)-day meat withdrawal period. Our investigation also found that your veterinarian administered (b)(4) on 5/23/2019 to the beef cow identified with ear tag number (b)(4) and advised you to observe a (b)(4)-day meat withdrawal period. You sold this cow on 5/28/19, before the withdrawal periods were completed.

Your extralabel use of (b)(4) and (b)(4)- specifically, the failure to observe the withdrawal periods- was not ordered by a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use of these drugs resulted in an illegal drug residue, in violation of 21 CFR 530.11(d). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).

We acknowledge your email response to the FDA Form 483 (Inspectional Observations) dated October 26, 2019. In your response you, “apologize[d] for the inconvenience” but did not address the inspectional observations or the steps you are taking to correct these issues.

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Tamara J. Umscheid, Compliance Officer, at 8050 Marshall Drive, Suite 205, Lenexa, Kansas, 66214. If you have any questions about this letter, please contact Officer Umscheid at (913) 495-5128.

Sincerely,
/S/

Cheryl A. Bigham
Program Division Director
Office of Human and Animal Foods – Division II West