Snellman Farms 6/1/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
June 1, 2012
WARNING LETTER CIN-12-302058-21
Mr. Peter Snellman, Owner
8151 State Route 669 Northwest
McConnelsville, Ohio 43756
Dear Mr. Snellman:
On March 6, 7, and 9, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your veal calf growing operation located at 8151 State Route 669 NW, McConnelsville, 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 (b)(4), you hauled (b)(4) calves to (b)(4), for slaughter as food. On or about (b)(4) slaughtered these animals. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from (b)(4) of the (b)(4) calves identified the presence florfenicol at 0.50 parts per million (ppm) in the liver of this animal. FDA has established a tolerance of 3.7 ppm for residues of florfenicol in the liver tissue of cattle as codified in Title 21, Code of Federal Regulations, Part 556.283 (21 C.F.R. 556.283). However, this tolerance does not apply to residues of florfenicol in calves to be processed for veal. As such, there is no acceptable level of residue associated with florfenicol in calves to be processed for veal. The presence of this drug in edible tissue from this animal in any 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. 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 drug (b)(4). Specifically, our investigation revealed that you did not use (b)(4), as directed by its approved labeling and your servicing veterinarian’s written prescription. 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 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 order of a licensed veterinarian within the context of a veterinarian/client/patient relationship.
Our investigation found that you administered the new animal drug (b)(4), to your calves to be processed for veal without following the animal class as stated in the approved labeling or the withdrawal period established by your servicing veterinarian. Your extralabel use of the new animal drug (b)(4), was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and resulted in an illegal 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 your servicing veterinarian’s written prescription 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 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 an update for 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 Compliance Officer Rabe at 513-679-2700, ext. 2163 or firstname.lastname@example.org.
Paul J. Teitell
R. L. Sommers, D.V.M.
Silver Lake Veterinary Clinic
9347 South State Road 15
Silver Lake, Indiana 46982
Ohio Department of Agriculture
Division of Animal Health
8995 East Main Street
Reynoldsburg, OH 43068-3399