Inspections, Compliance, Enforcement, and Criminal Investigations

South Fork Dairy, LLC 3/13/17

 

  

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Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772

 

March 13, 2017
 
 
WARNING LETTER
CIN-17-510210-03
 
 
Via United Parcel Service
 
Evan A. Barton, Owner
South Fork Dairy, LLC
698 Lakeshore Blvd.
Thornville, OH 43076
 
Dear Mr. Barton,
 
On August 24, October 3, and October 4, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your operation located at 8166 Lake Drive, Newark, Ohio 43056. 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 the FDA’s web page at www.fda.gov.
 
We found that you offered for sale animals for slaughter for food that were 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 December 28, 2015 you sold a bob veal calf, identified with back tags (b)(4) and (b)(4), and ear tag (b)(4), for slaughter as food. On or about December 31, 2015, (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 sulfamethazine at 49.7 part per million (ppm) in the liver and at 43.29 ppm in the muscle tissues. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle under Title 21, Code of Federal Regulations (C.F.R.), 556.670 (21 C.F.R. 556.670). The presence of sulfamethazine 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 revealed that on or about January 28, 2016 you sold a cow, identified with back tag (b)(4), for slaughter as food. On or about January 28, 2016, (b)(4), slaughtered this animal.  USDA/FSIS analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur (marker residue for ceftiofur) at 2.61 ppm in the kidney.  FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the kidney of cattle under 21 C.F.R. § 556.113. The presence of desfuroylceftiofur in edible tissues 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 revealed that on or about February 16, 2016, you sold a cow, identified with back tag (b)(4), for slaughter as food. On or about 02/16/16, (b)(4), slaughtered this animal.  USDA/FSIS analysis of tissue samples collected from this animal identified the presence of ampicillin at 0.05ppm in the kidney. FDA has established a tolerance of 0.01 ppm for residues of ampicillin in the kidney of cattle under 21 C.F.R. § 556.40. The presence of ampicillin in edible tissues 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 revealed that on or about July 25, 2016, you sold a bob veal calf with back tag (b)(4) and ear tag (b)(4) for slaughter as food.  On or about July 27, 2016, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of neomycin at 152.54 ppm in the kidney. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle under 21 C.F.R. Section 556.430. However, this tolerance does not apply to the use of Neomycin Oral Solution in calves to be processed for veal. There is no acceptable level of residue associated with the use of Neomycin Oral Solution in veal calves. The presence of this drug in edible tissues from this animal 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 completed treatment records. Specifically, you do not record the amount of medication administered, the name of the person administering the medication, the meat/milk withdrawal time, or if the medication was administered in accordance with the veterinarian’s order. Further, you fed milk from treated cows to calves which, in turn, were slaughtered for food for human consumption. 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 drugs Sustain III Calf Bolus (sulfamethazine, NADA 120-615), Excede (ceftiofur crystalline free acid, NADA 141-209), Polyflex (Ampicillin, NADA 55-030), and Neomycin Oral Solution (neomycin sulfate, ANADA 200-379).  Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling or veterinary prescription.  Use of these drugs 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 also found that you administered Sustain III Calf Bolus to a bob veal calf with back tags (b)(4) and (b)(4), and ear tag (b)(4), without following the dosage, duration of treatment, or withdrawal period as stated in the approved labeling. Your extralabel use of Sustain III Calf Bolus was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a), and your extralabel use of Sustain III Calf Bolus resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d).
 
Our investigation also found that you administered Excede to a cow with back tag (b)(4) without following the route of administration and withdrawal period as stated in the approved labeling. Your extralabel use of Excede was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a), and your extralabel use of Excede resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d). Ceftiofur crystalline free acid is prohibited for extralabel use in food producing animals by 21 C.F.R. 530.41(a)(13)(ii).
 
Our investigation also found that you administered Polyflex to the cow with back tag (b)(4) without following the withdrawal period as stated in the approved labeling. Your extralabel use of Polyflex was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a), and your extralabel use of Polyflex resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d).
 
Our investigation found that you administered Neomycin Oral Solution to a bob veal calf with back tag (b)(4) and ear tag (b)(4) without following the animal class as stated in the approved labeling. Your extralabel use of Neomycin Oral Solution was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a); your extralabel use of Neomycin Oral Solution was in or on feed, in violation of 21 C.F.R. § 530.11(b); and your extralabel use of Neomycin Oral Solution resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d).
 
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).
 
Our investigation also revealed that on or about November 29, 2015, you submitted a Consignor/Livestock Owner’s Certificate to (b)(4) that states that the animals presented for slaughter do not have illegal levels of drug residues.  On or about July 25, 2016, you delivered a bob veal calf which contained violative residues of neomycin from your farm to (b)(4).  On or about December 28, 2016, you delivered a bob veal calf, which contained violative residues of sulfamethazine, from your farm 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.
 
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.
 
Our office is in receipt of your letter dated October 16, 2016, addressing the deviations noted on the Form FDA 483, Inspectional Observations, issued at the close of the inspection, dated October 4, 2016. We have reviewed your response and find the corrective actions, in general, to be inadequate, as the response does not provide any representative documentation supporting your corrective actions. 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 Andrew Lang, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Andrew Lang at 513-679-2700 x2117.
 
  
Sincerely,
/S/ 
Steven B. Barber
District Director
Cincinnati District

 

Page Last Updated: 03/16/2017
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