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WARNING LETTER

South Fork Farms, LLC

Product:
Animal & Veterinary

Recipient:
South Fork Farms, LLC


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: 313-393-81 00
FAX: 313-393-8139 

 

WARNING LETTER
2015-DET-16
 
 
VIA UPS
 
July 30, 2015           
 
Mr. Charles O. Adams, Member & Co-Owner
South Fork Farms, LLC
8375 South Stoney Lake Road
Jackson, Michigan 49201
 
Dear Mr. Adams:
 
On May 14, 18, and 28, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8375 South Stoney Lake Road, Jackson, Michigan 49201-7203. 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 8, 2014, you sold a dairy cow, identified with ear tags # (b)(4) ((b)(4) bangle), #(b)(4), and #(b)(4), for slaughter as food.  On or about September 8, 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 2.31 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney tissue and the presence of 1.25 ppm of flunixin residue in the liver tissue. FDA has established a tolerance of 0.4 (ppm) for residues of desfuroylceftiofur in the target tissue (kidney) 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 (target tissue) of cattle as codified in 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. For example, you failed to maintain complete treatment records for your cows and bulls, or any treatment records for your calves. 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 drug Flunixin Injection (Flunixin Meglumine, injectable solution, ANADA #(b)(4)). Specifically, our investigation revealed that you did not use the Flunixin Injection as directed by the approved labeling or by the servicing veterinarian’s prescription. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a).
 
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 the Flunixin Injection (Flunixin Meglumine, injectable solution, ANADA #(b)(4)) to two cows identified with ear tags #(b)(4) (May 2015) and #(b)(4) (August 2014) without following the duration of treatment as stated on the approved drug labeling. Your extralabel use of the Flunixin Injection was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug 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 receipt of your letter sent in response to the Form FDA 483, dated June 10, 2015. However, this response is not adequate for the following reasons.  Your letter states that you have consulted with your veterinarian in regard to longer drug treatment duration, however, you have not provided a revised treatment protocol for review. Also included with the letter were copies of forms to be used for treatment records. However, we noted the forms do not provide for recording the length of the withdrawal periods for milk and meat, and the dates when the withdrawal periods end. Further, although your letter states that you are using the new form for your cows and calves, you have not provided copies of actual animal treatment records for our review.
 
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 Ms. Seri L. Essary, 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 Seri L. Essary at (313) 393-8150.
 
 
Sincerely,
/S/
Art O. Czabaniuk
District Director
Detroit District Office 
 
cc:       Mr. John L. Adams, Member & Co-Owner
            South Fork Farms, LLC
            8375 South Stoney Lake Road
            Jackson, Michigan 49201
 
            (b)(4)
 
            Ms. Melanie A. Hart
            Cervid and Reportable Disease Program Secretary
            Michigan Department of Agriculture and Rural Development
            Animal Industry Division
            HartM1@Michigan.gov