| Public Health Service Food and Drug Administration |
Cincinnati District Office |
Department of Health and Human Services
WARNING LETTER
CIN-11-65585-06
March 18, 2011
United Parcel Service
Mr. Kenneth D. Weaver, General Manager
Horizon Acres
6728 Zuercher Road
Dalton, Ohio 44618
Dear Mr. Weaver:
On November 10, 12, 19,24, 2010, and December 20, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your veal calf operation located at 6728 Zuercher Road, Dalton, Ohio 44618. 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 June 22, 2010, you sold an unidentified, untagged veal calf for slaughter as food. On or about June 22, 2010, (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 0.28 parts per million (ppm) of flunixin in the liver tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver of cattle as codified in 21 C.F.R. 556.286(b)(1)(i). However, this tolerance does not apply to use of Suppressor (flunixin meglumine) Injectable Solution, ANADA 200-308, in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with use of flunixin meglumine in veal calves (pre-ruminating calves). The presence of this drug in edible tissue 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 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 and segregate treated animals. 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 Suppressor (flunixin meglumine) ANADA 200-308, Dexamethasone ANADA 200-312, Ceftiflex sterile powder (ceftiofur sodium) ANADA 200-420, PennOne Pro (penicillin G procaine) NADA 65-010, Amoxicillin capsules NDC 65862-017-05, Sulfamethoxazole and Trimethoprim Double Strength tablets NDC 53746-272-05 (SMZ-TMP tablets), and Pennchlor 64 (chlortetracycline HCI) ANADA 200-295. Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. 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 flunixin meglumine to veal calves without following the withdrawal period as stated in the approved labeling. Your extralabel use of flunixin meglumine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel use of flunixin meglumine resulted in an illegal drug residue, in violation of 21 C.F.R. §
530.11(c).
Our investigation found that you administered dexamethasone to veal calves without following the route of administration and the withdrawal period as stated in the approved labeling. Your extralabel use of Dexamethasone was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11 (a).
Our investigation found that you administered ceftiofur sodium to veal calves without following the withdrawal period as stated in the approved labeling. Your extralabel use of ceftiofur sodium was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a).
Our investigation found that you administered penicillin G procaine to veal calves without following the route of administration and the withdrawal period as stated in the approved labeling. Your extralabel use of penicillin G procaine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a).
Our investigation found that you administered amoxicillin and sulfamethoxazole and trimethoprim (SMZ-TMP) to veal calves without following the route of administration and duration of the treatment as stated in their approved labeling. Your extralabel use of Amoxicillin and SMZ-TMP were not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11 (a) and your use of amoxicillin and SMZ-TMP in or on feed, is in violation of 21 C.F.R. § 530.11(b).
Our investigation found that you administered chlortetracycline HCI to veal calves without following the duration of treatment. Your use of chlortetracycline HCI was not under the supervision of a licensed veterinarian, and is in violation of 21 C.F.R. § 530.11(a) and your use of pennchlor 64 in or on feed, is in violation of 21 C.F.R. § 530.11(b). 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 drug(s) 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).
In addition, you adulterated the liquid animal feed within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you added sulfamethoxazole and trimethoprim, Amoxicillin, and chlortetracycline HCI, and you failed to use the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe under section 512(a)(2) of the FD&C Act, 21 U.S.C. § 360b(a)(2), and adulterated under section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6). Section 512 of the FD&C 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.
Your written response should be sent to Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Hunter at 513-679-2700 ext. 134.
Sincerely yours,
/S/
Teresa Thompson
District Director
Cincinnati District
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