- Animal & Veterinary
- Floyd Raber
- Issuing Office:
- Cincinnati District Office
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
November 19, 2014
VIA UNITED PARCEL SERVICE
5948 County Road 68
Millersburg, Ohio 44654-9434
Dear Mr. Raber:
On October 6, 8 and 14, 2014 the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5948 County Road 68, Millersburg, 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 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 March 26, 2014 you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about March 28, 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 sulfamethoxazole in the kidney tissue of this animal. FDA has not established a tolerance for residues of sulfamethoxazole in the edible tissues of calves intended for slaughter for veal. The presence of this drug in edible tissue 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 complete treatment records and failed to identify animals treated with medication. 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 human drug SMZ/TMP (Sulfamethoxazole and Trimethoprim Oral Suspension NDC 50383-823-16). Specifically, our investigation revealed that you did not use SMZ/TMP as directed by your servicing veterinarian’s prescription. Use of the drug in this manner is an extralabel use as defined under 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 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 SMZ/TMP to a bob veal calf identified with back tag (b)(4) without following the withdrawal period as prescribed by your servicing veterinarian. Your extralabel use of SMZ/TMP was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of SMZ/TMP 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 veterinarian’s prescribed 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).
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.
Our investigation also revealed that on July 21, 2011, you submitted a Consignor/Livestock Owner’s Certificate to (b)(4) that states that the animals presented for slaughter do not have an illegal level of drug residues. On March 26, 2014, (b)(4) delivered a bull calf, which contained violative residues of sulfamethoxazole, from your farm to (b)(4) In a signed Affidavit on October 8, 2014, you stated that you did not inform the hauler or auction that the bull calf had been medicated and the withdrawal period had not been met. 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.
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 Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Mr. Rabe at (513) 679-2700, ext. 2163or Email at: Stephen.Rabe@fda.hhs.gov
Paul J. Teitell