Inspections, Compliance, Enforcement, and Criminal Investigations
VDS Farms, L.L.C. 29-Oct-07
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
October 29, 2007
Mr. Jacques Heemskerk, General Manager
VDS Farms, L.L.C.
14461 South 44th Street
Fulton, Michigan 49052
Dear Mr. Heemskerk:
An investigation of your dairy operation located at 14461 South 44th Street, Fulton, Michigan and 8426 South Avenue East, Scotts, Michigan, conducted by a representative of the U.S. Food and Drug Administration (FDA) on June 11-13, 2007, confirmed that you offered two animals for sale for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] 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 11, 2006, you sold a dairy cow identified with back tag [redacted] through [redacted] for slaughter as food. On or about December 12, 2006, this animal was slaughtered at [redacted]. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 1.11 parts per million (ppm) sulfadimethoxine in the liver and 0.65 ppm sulfadimethoxine in the muscle of the cow. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Part 556.640(b)(1) [21 C.F.R. 556.640 b)(1)].
In addition, on or about March 1, 2007, you sold a dairy cow identified with bach tag number [redacted] to [redacted] slaughter as food. On or about March 2, 2007, this animal was slaughtered at [redacted]. USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 0.383 ppm [redacted] in the liver of this cow. A tolerance of 125 parts per billion (or, 0.125 ppm) has been established for residues of [redacted] in the liver of cattle as codified in 21 C.F.R. 556.286(b)(1)(i).
The presence of these drugs in edible tissues in these amounts from these animals causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] of the Act.
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 maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Act.
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 a 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, 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 300 River Place Dr., Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Compliance Officer Jankowski at 313-393-8125.
Joann M. Givens
Detroit District Office