Inspections, Compliance, Enforcement, and Criminal Investigations
Roberts Ranch of Oklahoma LLC 9/11/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
September 11, 2012
Norman Kronseder, President
The Hanor Company of Wisconsin, LLC
Roberts Ranch of Oklahoma LLC
E4614 Highway 14 & 60
Spring Green, Wisconsin 53588
Dear Mr. Kronseder:
On April 2, 3, 12, and 23, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your Roberts Ranch of Oklahoma LLC, swine raising operation located at Route 1, Box 30A, Ames, Oklahoma. 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 November 8, 2011, you sold (b)(4) pigs for slaughter as food. On or about November 8, 2011, (b)(4), slaughtered these animals. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from one of these animals identified the presence of penicillin in the kidney and muscle tissues. FDA has not established a tolerance for residues of penicillin in the edible tissues of swine. The presence of this drug in edible tissues 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 new animal drug (b)(4) (penicillin G procaine) Injectable Suspension, NADA (b)(4). Specifically, our investigation revealed that you did not use penicillin G procaine as directed by its approved labeling. Use of this drug in this manner is an extra-label use. See 21 C.F.R. § 530.3(a).
The extra-label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label 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 penicillin G procaine to a culled sow without following the dose as stated in the approved labeling. Your extra-label use of penicillin G procaine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a), and your extra-label use of penicillin G procaine resulted in illegal drug residues, 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 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.
We acknowledge that during our investigation management provided copies of revised treatment records and Animal Movement Forms, and stated that they will keep the treatment records and Animal Movement Forms together when animals are sent to slaughter. This corrective action is not adequate because if the treatment records and Animal Movement Forms become separated, traceback information for all involved animals will be lost.
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 Seri Essary, Compliance Officer, U.S. Food and Drug Administration, 4040 N. Central Expressway, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer Essary at (214)253-5335 or the above address.
Reynaldo R. Rodriguez, Jr.