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WARNING LETTER

Jerald and Janine Stewart Farm MARCS-CMS 527991 —

Product:
Animal & Veterinary

Recipient:
Jerald and Janine Stewart Farm


United States

Issuing Office:
Kansas City District Office

United States


 

   

Black HHS-Blue FDA Logo

 

 

 
Office of Human and Animal Food-West Division II

8050 Marshall Drive - Suite 205

Lenexa, Kansas 66214-1524

913-495-5100

 

WARNING LETTER
 
VIA UNITED PARCEL
SERVICE SIGNATURE REQUIRED
 
June 28, 2017
 
Jerald E. Stewart, Jr., Co-Owner
Janine Stewart, Co-Owner
Jerald and Janine Stewart Farm
57678 Highway 12
Newcastle, NE 68757
 
Reference: CMS # 527991
 
Dear Mr. and Mrs. Stewart:
 
On June 6, 8-9, 2017, the U.S. Food and Drug Administration (FDA) conducted an investigation of your beef cow-calf operation located at 57678 Highway 12, Newcastle, Nebraska. 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 or about March 1, 2017, you delivered a cow, identified with back tag (b)(4) and Bangle tag (b)(4) for slaughter as food. On or about March 1, 2017, (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 10.2 ppm of Flunixin in the liver. FDA has established a tolerance of 0.125 ppm for residues of Flunixin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.286 (21 C.F.R. § 556.286).
 
Also USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 10.395 ppm of Desfuroylceftiofur in the kidney. FDA has established a tolerance of 0.4 ppm for residues of Desfuroylceftiofur in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.113 (21 C.F.R. § 556.113).
 
Also USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 23.0 ppm of Oxytetracycline in the kidney. FDA has established a tolerance of 12 ppm for residues of  Oxytetracycline in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.500 (21 C.F.R. § 556.500).
 
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 Act, 21 U.S.C. § 342(a)(2)(C)(ii).
 
Residue
Level (ppm)
Tolerance (ppm)
Tissue
Oxytetracycline
23.0
12
Kidney
Desfuroylceftiofur
10.395
0.4
Kidney
Flunixin
10.2
0.125
Liver
 
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. 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 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 Danial S. Hutchison, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, KS 66214.  If you have any questions about this letter, please contact Compliance Officer Hutchison at 913-495-5154 or danial.hutchison@fda.hhs.gov.
 
Sincerely,
/S/  
Cheryl A. Bigham
Program Division Director
Office of Human and Animal Foods
Division II West
 
 
cc:
Steve Gramlich Program Manager
Animal & Plant Health Protection
Nebraska Department of Agriculture
PO Box 94787,
Lincoln, NE 68509-4787
 
(b)(4)