Inspections, Compliance, Enforcement, and Criminal Investigations
Cedar Ridge Farms 4/2/13
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) 679-2775
April 2, 2013
Via United Parcel Services
Mr. Jack H. Durbin, Owner
Cedar Ridge Farms
3911 Salt River Road
Leitchfield, Kentucky 42754
Dear Mr. Durbin:
On January 28, 31 and February 1, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at Cedar Ridge Farms, 3911 Salt River Road, Leitchfield, 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 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 or about November 6, 2012, you sold a dairy cow, identified with back tag (b)(4) for slaughter as food. On or about November 7, 2012, (b)(4) slaughtred 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 19.86 parts per million (ppm) of oxytetracycline in the kidney tissue, 1.45 ppm of sulfadimethoxine in the liver tissue and 1.089 ppm of sulfadimethoxine in the muscle tissue. FDA has established a tolerance of 12 parts per million (ppm) for residues of oxytetracycline in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.500 (21 C.F.R. 556.500). FDA has established a tolerance of 0.10 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in 21 C.F.R. 556.640. The presence of these drugs in edible tissues from this animal in these amounts 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. For example, you failed to maintain complete treatment records. 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 new animal drugs Di-Methox ANADA 200-038 (sulfadimethoxine) and Agrimycin 200 ANADA 200-306 (oxytetracycline). Specifically, our investigation revealed that you did not use oxytetracycline and sulfadimethoxine as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. See 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 you administered oxytetracycline and sulfadimethoxine to a cow with back tag (b)(4) without following the recommended indications for use as stated in the approved labeling. Your extralabel use of oxytetracycline was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of oxytetracycline resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of these drugs was not in conformance with their approved labelingand 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).
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 Allison C. Hunter, 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 Hunter at 513-679-2700 X2134 or Allison.email@example.com.
Paul J. Tietell
cc: Dr. Isabel Arrington, Director TA/C
United States Department of Agriculture (USDA)
Food Safety and Inspection Service
Landmark Center, Suite 300
1299 Farnam Street
Omaha, Nebraska 68102