Vander Hoff Bros. Dairy, L.L.C. 6/30/15
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Detroit District|
300 River Place
Detroit. Ml 48207
June 30, 2015
Stephen L. Vander Hoff, Co-Owner
Leo W. Vander Hoff, Co-Owner
Vander Hoff Bros. Dairy, LLC
1216 Grove Road
Reading, Michigan 49274-9531
Dear Messrs. Vander Hoff:
On March 18, April 8, and April 13, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1216 Grove Rd., Reading, Michigan. 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 June 26, 2014, you sold a dairy cow, identified with ear tag (b)(4) and back tag (b)(4), for slaughter as food. On or about June 27, 2015, (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 (marker residue for ceftiofur) at 2.15 parts per million (ppm) in the muscle tissue and at 8.41 ppm in the kidney tissue. USDA/FSIS analysis of tissue samples collected from this animal also identified the presence of flunixin at 0.333 ppm in the liver tissue. FDA has established a tolerance of 1 ppm for residues of desfuroylceftiofur in the muscle tissue of cattle and a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the kidney tissue of cattle, as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.113(b)(3). FDA has established a tolerance of 0.125 ppm flunixin in liver tissue of cattle, as codified in 21 C.F.R. 556.286(b)(1)(i). 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 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).
We also found that you adulterated the new animal drug VetaMeg (flunixin meglumine, ANADA 200-308). Specifically, our investigation revealed that you did not use VetaMeg 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 you administered VetaMeg to a dairy cow, identified with ear tag (b)(4) and back tag (b)(4), without following the route of administration and without following the slaughter withdrawal period as stated in the approved labeling. Your extralabel use of VetaMeg was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of VetaMeg 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 the 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.
Our investigation also revealed that on or about January 1, 2014, Mr. Stephen L. Vander Hoff provided to (b)(4) a Livestock Owner Certificate that states that the animals presented for slaughter are not adulterated within the meaning of the FD&C Act. On or about June 26, 2014, you delivered a dairy cow identified with ear tag (b)(4) and back tag (b)(4), which contained violative residues of desfuroylceftiofur and flunixin, to (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
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.
Please submit your response to Seri Essary, Compliance Officer, at the above letterhead address. If you have any questions please contact Ms. Essary at (313) 393-8150.
Art O. Czabaniuk
Detroit District Office
Ms. Melanie A. Hart
Cervid and Reportable Disease Program Secretary
Michigan Department of Agriculture and Rural Development
Animal Industry Division