Public Health Service
Food and Drug Administration
300 River Place
Detroit, Ml 48207
August 4, 2016
Mr. Michael P. Noll, President
Noll Dairy Farm, Inc.
7202 Fargo Road
Croswell, Michigan 48422
Dear Mr. Noll:
On February 17 through March 3, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 7202 Fargo Rd, Croswell, Michigan 48422. 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 September 21, 2015, you sold a culled dairy cow, identified with back tag #(b)(4) and ear tag (b)(4) for slaughter as food. On or about September 22, 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, a marker residue for ceftiofur, at 3.4 parts per million (ppm) in the kidney tissue and the presence of flunixin at .144 ppm in the liver. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113, 21 C.F.R. 556.113 and a tolerance of 0.125 ppm for residues of flunixin in the liver, as codified at 21 C.F.R. 556.286. 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.
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) 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.
Our investigation also revealed that on or about September 14, 2014 you provided to (b)(4), a signed certification that states that the livestock you sell do not have illegal levels of drug residues. On or about September 21, 2015, you sold a culled dairy cow, identified with back tag #(b)(4) and ear 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.
Your written response should be sent to LCDR Kelli Wilkinson, 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 LCDR Kelli Wilkinson at (313) 393-8120 or email at Kelli.Wilkinson@fda.hhs.gov.