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  5. Jerry Slabaugh - 09/16/2014
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WARNING LETTER

Jerry Slabaugh Sep 16, 2014

Jerry Slabaugh - 09/16/2014


Recipient:
Jerry Slabaugh


United States

Issuing Office:
Cincinnati District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775

 

September 16, 2014
 
WARNING LETTER
CIN-14-438439-23
                                                                                                                                                                               
 
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Jerry Slabaugh, Owner
12813 County Road 265
Kenton, Ohio 43326
 
Dear Mr. Jerry Slabaugh;
 
On June 16, 17, 26, 30, July 1, and 3, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 12813 County Road 265 Kenton, Ohio. 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 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 20, 2014, you sold a bob veal calf, identified with back tag (b)(4) for slaughter as food. On or about February 21, 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 0.123 parts per million (ppm) of sulfamethazine in the liver and the presence of tulathromycin in the kidney.  FDA has established a tolerance of 0.10 ppm for residues of sulfamethazine in the uncooked edible tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.670 (21C.F.R. 556.670). FDA has not established a tolerance for residues of tulathromycin in the edible tissues of bob veal calves. 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. 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 Draxxin (tulathromycin, NADA141-244) and Aureo S 700 2G Crumbles (chlortetracycline plus sulfamethazine NADA 035-805). Specifically, our investigation revealed that you did not use Draxxin as directed by its approved labeling or veterinary prescription. Our investigation also revealed that you did not use Aureo S 700 2G Crumbles as directed by its approved labeling. 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 found that you administered Draxxin to a bob veal calf with back tag (b)(4) without following the indication for use as stated in the approved label. Your extralabel use of Draxxin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of Draxxin resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because your use of this drug was not in conformance with the 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).
 
Our investigation also found that you administered Aureo S 700 2G Crumbles to a bob veal calf with back tag (b)(4) without following the indication for use as stated in the approved label. Your extralabel use of Aureo S 700 2G Crumbles was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of Aureo S 700 2G Crumbles resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with the 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)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6).  Section 512 of the Act, 21 U.S.C. § 360b, and 21 C.F.R. § 530.11(b) do not permit the extralabel use of medicated feed.
 
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.
 
Please send your reply to the Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237, Attention: Allison Hunter. If you have any questions about this letter, please contact Compliance Officer Hunter at 513.679.2700 ext. 2134 or by email at allison.hunter@fda.hhs.gov.
 
 
Sincerely yours,
/S/
Paul J. Tietell
District Director
Cincinnati District
 
cc:     Dr. Toney Forshey, Chief
         Ohio Department of Agriculture
         Division of Animal Health
         8995 East Main Street
         Reynoldsburg, OH 43068-3399