Inspections, Compliance, Enforcement, and Criminal Investigations
Martin-Vue Farms 18-Aug-05
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
August 18, 2005
Mr. Kevin R. Martin, Owner
21918 State Road 119
Goshen, IN 46526-7474
Dear Mr. Martin:
An investigation of your dairy operation located at 21918 State Road 119, Goshen, Indiana, conducted by a representative of the U.S. Food and Drug Administration (FDA) on April 20-21, 2005, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342 (a)(2)(C)(ii)1 and 402(a)(4) [21 U.S.C. 342 (a)(4)] of the Federal Food, Drug and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about December 15, 2004, you sold a dairy cow for slaughter as food to [redacted], where it was assigned back tag number 0188. On or about December 17, 2004 this animal was slaughtered at the [redacted]. The United States Department of Agriculture, Food Safety and lnspection Service (USDAIFSIS} analysis of tissue samples collected from that animal identified the presence of [redacted] gentamicin in the kidney tissue of the dairy cow. No tolerance as been established for residues of gentamicin in the edible tissues of bovine species as codified in Title 21, Code of Federal Regulations, Part 556.300 (21 C.F.R. 556.30). The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the 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 animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to have a system to control the administration of drug treatments to animals, you failed to maintain treatment records, and you lack an adequate inventory system for determining the quantities of drugs used to medicate your animal. 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 above violations and to establish procedures whereby such 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 taw 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, 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 Ms. Judith Jankowski, Compliance Officer, U.S. Food and Drug Administration at the above address. If you have questions about this letter, please contact Ms. Jankowski at 313-333-8125.
Joann M. Givens
Detroit District Office