Inspections, Compliance, Enforcement, and Criminal Investigations
Red Arrow Dairy, LLC 22-Oct-08
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
October 22, 2008
Mr. Rudolf P. DeJong, Jr., President
Red Arrow Dairy, LLC
50 64th Avenue
Coopersville, Michigan 49404
Dear Mr. DeJong,
On May 23, 2008, through June 4, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 69444 County Road 687, Hartford, Michigan 49057-8671. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the 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 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 Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the 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 December 11, 2007, you sold a bob veal calf, identified with back tag number [(b)(4)] While you stated that you intended the calf to be raised as a steer by the purchaser, you did not notify the purchaser that it should not be slaughtered for use as food. On December 13, 2007, [(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 0.13 part per million (ppm) of penicillin in the kidney and 0.151 ppm of flunixin in the liver. FDA has not established a tolerance for residues of penicillin or flunixin in the edible tissues of calves to be processed as veal. The presence of these drugs in edible tissues 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. For example, you failed to maintain adequate drug treatment records for animals medicated on your farm. 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 had 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.
Finally, we note that this is not the first time that illegal residues have been found in animals from your farm. On May 4, 2007, you sold a dairy cow, identified with ear (bangle) tag # [(b)(4)] for slaughter as food. On May 7, 2007, [(b)(4)] slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 0.104 ppm of flunixin in the muscle. FDA has established a tolerance of 0.025 ppm for residues of flunixin in the muscle of cattle as codified in 21 C.F.R 556.286.
Your written response should be directed to Judith A. Jankowski, Compliance Officer, 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 Jankowski at 313-393-8125; fax 313-393-8139; email firstname.lastname@example.org.
Joann M. Given
Detroit District Office
cc: Bernard Senn, DVM
18480 County Road 46
New Paris, Indiana 46553-9643
Steven L. Halstead, DVM, MS, State Veterinarian
Michigan Department of Agriculture
Animal Industry Division
P.O. Box 30017
Lansing, Michigan 48909