- Animal & Veterinary
- Robin Martin
- Issuing Office:
- Detroit District Office
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
300 River Place
Detroit, Ml 48207
June 28, 2016
Mr. Robin G. Martin, Owner
1050 Arnold Road
Snover, Michigan 48472
Dear Mr. Martin:
On April 26, 28, and May 4, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1050 Arnold Road, Snover, Michigan 48472. 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 July 28, 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 July 29, 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 desfuroylceftiofur, a marker residue for ceftiofur, at 5.48 parts per million (ppm) in the kidney tissue. 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. 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 treatment records and we found expired animal drugs on-site. 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 that your overall operation and the food you distribute is in compliance with the law.
We acknowledge receipt of your written response dated May 23, 2016 regarding the Form FDA 483 Inspectional Observations issued to you at the close of the above inspection. Your response states that you sent a cow for slaughter that was treated and you are now keeping better records, including: now using a computer system to record treatments; retaining the treatment records; obtaining extralabel prescriptions for all extralabel uses; and reviewing all treatment records prior to selling a cow. We acknowledge your statement indicating your records will now include indications for use, dosage given, and route of administration; however, from the current treatment records dated 8/24/15-2/13/16, the dose, route, and indication for use was not recorded. Consequently, your response is inadequate due to the lack of documentation illustrating the inclusion of indications for use, dosage given, and route of administration into your record keeping practices.
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 July 26, 2011 you provided to (b)(4), a signed certification that states that the livestock you sell do not have illegal levels of drug residues. According to the certificate, it remains in effect until the undersigned delivers written notice of revocation to the (b)(4) market / staff. On or about July 28, 2015 you delivered a dairy cow identified with ear tag (b)(4) (subsequently identified with back tag (b)(4)), which contained violative residues of desfuroylceftiofur 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
Art O. Czabaniuk
Detroit District Office