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  5. Merlin R. Yoder - 04/22/2015
  1. Warning Letters

WARNING LETTER

Merlin R. Yoder

Product:
Animal & Veterinary

Recipient:
Merlin R. Yoder


United States

Issuing Office:
Detroit District Office

United States


   

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-10
 
VIA UPS
 
April 22, 2015
 
 
Merlin R. Yoder, Co-Owner
Mary J. Yoder, Co-Owner
29700 Mountain Road
Colon, Michigan 49040-9710
 
 
Dear Mr. and Mrs. Yoder:
 
On February 25, 2015, and March 13, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 29700 Mountain Road, Colon, 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 November 5, 2014, you sold a dairy cow identified with back tag (b)(4) (ear tag (b)(4)) for slaughter as food.  On or about November 6, 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 gentamicin in the animal’s kidney tissue and 1.38 ppm tilmicosin in the liver. FDA has established a tolerance of 1.2 ppm for residues of tilmicosin in the liver tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.735 (21 C.F.R. 556.735). However, this tolerance does not apply to the use of tilmicosin in female dairy cattle 20 months of age or older, and there is no acceptable level of residue associated with the use of this drug in female dairy cattle 20 months of age or older.  Further, FDA has not established a tolerance for residues of gentamicin in the edible tissues of cattle. 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 for your animals. 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 drugs Bactracillin G (penicillin G procaine, NADA 065-010), and VetaMeg (flunixin meglumine, ANADA 200-308). Specifically, our investigation revealed that you did not use penicillin G procaine and flunixin meglumine as directed by their approved labelingor veterinary prescription.  Use of these drugs in this manner is an extralabel use. See 21 C.F.R. 530.3(a). We have enclosed a copy for your reference. 
 
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 Bactracillin G to a cow identified with back tag (b)(4) (ear tag (b)(4)) without following the dosage, dosage per injection site, and indication for use as stated in the approved label. Our investigation also found that you administered VetaMeg to a cow identified with back tag (b)(4) (ear tag (b)(4)) without following the route of administration and indication for use as stated in the approved label. Your extralabel use of Bactracillin G and VetaMeg was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a).  Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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. 
 
We acknowledge your unsigned response sent via mail and received on March 25, 2015. Your response did not provide documentation demonstrating the corrections that have been made.
 
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 Seri Essary, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Compliance Officer Essary at 313-393-8150.
 
 
Sincerely,
/S/ 
Art O. Czabaniuk
District Director
Detroit District Office
 
cc:      
Ms. Melanie A. Hart
Cervid and Reportable Disease Program Secretary
Michigan Department of Agriculture and Rural Development
Animal Industry Division
HartM1@Michigan.gov