Inspections, Compliance, Enforcement, and Criminal Investigations
Goodlett Dairy Farm 7/22/13
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
July 22, 2013
via United Parcel Service
Mr. James Christopher Goodlett, Owner
Goodlett Dairy Farm
1656 Talmage Mayo Road
Harrodsburg, KY 40330
Dear Mr. Goodlett:
On June 7, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1715 Talmage Mayo Road, Harrodsburg, Kentucky 40330. 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 February 26, 2013, you sold a dairy cow, identified with back tag (b)(4) for slaughter as food. On or about February 26, 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 desfuroylceftiofur, a metabolite of ceftiofur, at 0.44 parts per million (ppm) in the kidney tissue, florfenicol at 5.30 ppm in the liver tissue and 0.51 ppm in the muscle tissue, the presence of ciprofloxacin and cefazolin in the kidney tissue, and sulfamethazine at 16.62 ppm in the liver tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113, 21 C.F.R. 556.113, a tolerance of 3.7 ppm in the liver tissue and 0.3 ppm of florfenicol in the muscle tissue of cattle as codified at 21 C.F.R. 556.283, and a tolerance of 0.1 ppm of sulfamethazine in the uncooked edible tissues of cattle as codified at 21 C.F.R. 556.670. FDA has not established a tolerance for residues of ciprofloxacin and cefazolin in the edible tissues of cattle. 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 treatment records, identify animals housed on-site, segregate treated animals and dispose of expired drugs. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
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 Allison C. Hunter at (513) 679-2700, Ext. 2134 or email at Allison.Hunter@fda.hhs.gov.
Paul J. Teitell