Inspections, Compliance, Enforcement, and Criminal Investigations

Schneider Dairy 1/30/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

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

 

Warning Letter
2015-DET-06
 
January 30, 2015
 
VIA UPS
 
Mr. Rick E. Schneider, Co-Owner
Schneider Dairy, LLC
12375 Lehman Road
Westphalia, Michigan 48894-9756
 
 
Dear Mr. Schneider:
 
On October 1, 2014 and November 3, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 12375 Lehman Road, Westphalia, Michigan 48894-9756. 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 February 4, 2014, you sold a culled dairy cow identified with ear tag #(b)(4) and back tag #(b)(4)  for slaughter as food. On or about February 5, 2014, (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 4.64 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney (target 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 this drug in edible tissue from this animal in this amount 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 failed to maintain complete treatment records. Your treatment records lack the route of administration and required withdrawal times. For example, the invoice from the veterinary clinic lacked the route of administration and required withdrawal time. This is Schneider Dairy’s only record that Cow #(b)(4)  was medicated on February 1, 2014.   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.
 
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 Cicely N. Vaughn, 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 Cicely N. Vaughn at (313) 393-8297 or e-mail at cicely.vaughn@fda.hhs.gov.
 
Sincerely yours,
/S/ 
Art O. Czabaniuk
District Director
Detroit District Office
 
cc:       
Mr. Doug K. Schneider, Co-Owner
Schneider Dairy, LLC
12375 Lehman Road
Westphalia, Michigan 48894-9756
 
Dr. Jesse W. Veenstra, D.V.M.
Sterner Veterinary Clinic P.C.
821 N. Jefferson Street
Ionia, Michigan 48846
 
Ms. Melanie A. Hart
Cervid and Reportable Disease Program Secretary
Michigan Department of Agriculture and Rural Development
Animal Industry Division
HartM1@Michigan.gov 

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