| 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) 679-2771 |
Department of Health and Human ServicesSeptember 8, 2010
Via United Parcel Service
WARNING LETTER
CIN-10-127191-22
Mr. Roy L. Raber, Owner
Raber View Holstein
7029 County Road 201
Millersburg, Ohio 44654
Dear Mr. Raber:
On August 3 and 9, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 7029 County Road 201, Millersburg, Ohio. 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 January 7, 2010, you sold a bob veal calf, identified with the auction's backtag #(b)(4), for slaughter as food. On or about January 8, 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 of 0.829 parts per million (ppm) of sulfamethoxazole in the muscle and 0.484 ppm of sulfamethoxazole in the liver. FDA has not established a tolerance for residues of sulfamethoxazole in the edible tissues of cattle. The presence of this drug in edible tissue from this animal in these amounts 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 treatment records for the animals you produce. 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 sulfamethoxazole and trimethoprim (800 mg/160 mg per tablet). Specifically, our investigation revealed that you did not use sulfamethoxazole
and trimethoprim as directed by its approved labeling. Use of sulfamethoxazole and trimethoprim in this manner is an extralabel use. Title 21, Code of Federal Regulations (C.F.R.), Section 530.3(a) (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 the human drug sulfamethoxazole and trimethoprim tablets to a bull calf without following the withdrawal period as stated in the approved labeling or any written directions by a licensed veterinarian. Your extralabel use of sulfamethoxazole and trimethoprim tablets was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a); and your extralabel use of sulfamethoxazole and trimethoprim tablets 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 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 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 Mark E. Parmon, 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 Mark E. Parmon at (513) 679-2700 Ext. 162.
Sincerely yours,
/S/
Teresa C. Thompson
District Director
Cincinnati District
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