| Public Health Service Food and Drug Administration |
| Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771 |
Department of Health and Human Services
May 12, 2011
WARNING LETTER VIA United Parcel Service
CIN-11-176972-15
Hugh A. Byron
267 Colliver Road
Hillsboro, Kentucky 41049-9289
Dear Mr. Byron:
On February 14 and 15, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 267 Colliver Road, Hillsboro, 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 July 7, 2010, you sold a cow, identified with ear tag (b)(4) and back tag (b)(4) for slaughter as food. On or about July 8, 2010, (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 a detectable level of gentamicin and 5.61 parts per million (ppm) of desfuroylceftiofur in the kidney. FDA has not established a tolerance for residues of gentamicin in edible tissues of cattle. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113 (21 C.F.R. § 556.113). The presence of these drugs 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).
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 for your cattle. 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 drug ceftiofur (Excede Sterile Suspension, NADA 141-209). Specifically, our investigation revealed that you did not use ceftiofur as directed by its approved labeling. Use of this drug 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 during July 2010, you administered ceftiofur to one of your dairy cows identified with ear tag (b)(4) without following the pre-slaughter withdrawal period as stated in the approved labeling. Your extralabel use of ceftiofur was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11 (a) and, your extralabel use of ceftiofur resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11 (d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused this 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.
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 Mark E. Parmon, 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 Mark E. Parmon at (513) 679-2700 Ext. 2162.
Sincerely yours,
/S/
Teresa C. Thompson
District Director
Cincinnati District
cc: Dr. Isabel Arrington, Director TA/C
United States Department of Agriculture (USDA)
Food Safety and Inspection Service (FSIS)
Landmark Center, Suite 300
1299 Farnam Street
Omaha, Nebraska 68102
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