| Public Health Service Food and Drug Administration |
| PHILADELPHIA DISTRICT 900 U.S. Customhouse 2nd and Chestnut Streets Philadelphia, PA 19106 Telephone: 215-597-4390 FAX: 787-729-6658 |
Department of Health and Human ServicesWARNING LETTER
10-PHI-05
April 1, 2010
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
John B. Yurkanin, Owner
Rd 3, Box 73
Columbia Cross Roads, Pennsylvania 16914
Dear Mr. Yurkanin:
On January 13 through January 25, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at Rd 3, Box 73, Columbia Cross Roads, Pennsylvania. 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 September 14, 2009, you sold a dairy cow, identified with back tag (b)(4) for human consumption. On or about September 15, 2009, (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 4.02 parts per million (ppm) in the liver tissue and 1.31 ppm in the muscle tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.670 (21 C.F.R. 556.670). The presence of this drug 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 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. Your records did not include the drug used, the dosage amount, the route of administration, and who administered the drug. 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).
We also found that you adulterated the new animal drug sulfamethazine. Specifically, our investigation revealed that you did not us Supra Sulfa III (Antibacterial Sulfamethazine Sustained Release Bolus), (b)(4) as directed by its approved labeling. 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 Act only if the extralabel use complies with sections 512(a)(4) and (5) of the 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 Supra Sulfa III (Antibacterial Sulfamethazine Sustained Release Bolus) to a dairy cow, identified with back tag (b)(4) without following the indications for use and withdrawal period contained in the approved labeling. Your extralabel use of Supra Sulfa III (Antibacterial Sulfamethazine Sustained Release Bolus) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a). Your extralabel use of sulfamethazine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11 (d). Because your extralabel use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. 530, you caused the drugs to be unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501 (a)(5) of the 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.
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 Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions regarding this letter, please contact Compliance Officer, Robin M. Rivers at 215-717-3076 or via e-mail at Robin.Rivers@FDA.HHS.GOV.
Sincerely,
/s/
Kirk Sooter
District Director
Philadelphia District Office
Enclosure: FDA-483 dated January 13 - 25, 2010
cc: Dr. David R. Griswold, Acting Director
Pennsylvania Department of Agriculture
Bureau of Animal Health and Diagnostic Services (BAHDS)
2301 North Cameron Street
Harrisburg, Pennsylvania 17120
United States Department of Agriculture
Food Safety and Inspection Service
Office of Policy, Program and Employee Development
1299 Farnam Street, Suite 300
Omaha, Nebraska 68102
Attention: Residue Staff
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