Inspections, Compliance, Enforcement, and Criminal Investigations
Smith Dairy 12/4/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
December 4, 2013
Craig D. Smith
1279 Smith Pike
Flemingsburg, Kentucky 41041
Dear Mr. Smith:
On July 23-24 and 26, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1279 Smith Pike, Flemingsburg, Kentucky. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the internet through links on FDA’s web page at www.fda.gov.
We found that you offered for sale an animal for slaughter 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 you sold a dairy cow identified with ear tag # (b)(4) and back tag # (b)(4) for slaughter as food. On or about February 6, 2013, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.64 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney. FDA has established a tolerance of 0.4 parts per million (ppm) for residues of desfuroylceftiofur in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113(b)(3)(i) (21 C.F.R. 556.113(b)(3)(i)). The presence of this drug in edible tissue from this animal in this amount cause 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. For example, you failed to maintain treatment records, you failed to identify and to segregate treated animals, and you failed to maintain an adequate inventory of drugs used to treat your animals and kept expired medications in your drug inventory. 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).
We also found that you adulterated the drug Excede (NADA 141-209, ceftiofur crystalline free acid). Specifically, our investigation revealed that you did not use Excede as directed by the approved labeling. Use of the drug in this manner is an extra-label use. 21 C.F.R. 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel 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 C.F.R. 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.
Our investigation found that your administered Excede to dairy cow identified with ear tag #(b)(4) without following the indications for use and route of administration as stated in the approved labeling. Your extra-label use of Excede was in violation of 21 C.F.R. 530.11(a). Certain uses of ceftiofur are prohibited for extra-label use in cattle by 21 C.F.R. 530.41(a)(13)(ii). Because your use of this drug was not in conformance with the approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug 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).
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.
We acknowledge that you informed our investigator that you are no longer conducting dairy operations at your facility. However, we also note that our investigator reported that you continue to maintain dairy cattle on your farm. Your corrective action letter should address how you will prevent future violative tissue residues in your remaining animals.
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 in your remaining animals.
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 Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Rabe at 513-679-2700, ext. 2163 or email@example.com.
Paul J. Teitell