Public Health Service Food and Drug Administration
Detroit District 300 River Place Suite 5900 Detroit, Ml 48207 Telephone: 313-393-8100 FAX: 313·393·8139
November 15, 2016
Mr. Jack Van Drie, Owner
Jack Van Drie
11220 Turnerville Road
Marion, MI 49665-9311
Mr. Van Drie:
On June 2 and June 14, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 11220 Turnerville Road, Marion, Michigan. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 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. 360(b). 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 29, 2016 you sold a dairy cow identified with ear tag number (b)(4), back tag number (b)(4), and retain tag number (b)(4) for slaughter as food. On or about March 1, 2016, (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 oxytetracycline at a level of 12.51 parts per million (ppm) in the kidney and flunixin at a level of 0.35 ppm in the liver. FDA has established a tolerance of 12 ppm for residues of oxytetracycline in the kidney of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.500 (21 C.F.R. 556.500) and 0.125 ppm for residues of flunixin in the liver of cattle as codified in 21 C.F.R. 556.286. The presence of these drugs in the edible tissues from this animal in these amounts causes the food to be adulterated under 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).
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 your overall operation and the food you distribute are 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:
Tina M. Pawlowski
U.S. Food and Drug Administration
300 River Place, Suite 5900
Detroit, Michigan 48207
If you have any questions about this letter, please contact Compliance Officer Pawlowski at (313) 393-8217 or by email at firstname.lastname@example.org.