Inspections, Compliance, Enforcement, and Criminal Investigations
Rancho Cantera 1/18/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
January 18, 2013
Via UPS Next Day
Jake Bosman, Owner
Rancho Cantera, LLC
2866 N. Sunnyside Rd.
Kent, IL 61044-9605
Dear Mr. Bosman:
On November 19, and 26, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 2866 North Sunnyside Road, Kent, Illinois. 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 the 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. 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 18, 2012, you sold a Holstein dairy cow, to (b)(4) for slaughter as food. The cow was identified with ear tag number (b)(4), and tagged with (b)(4) tag number (b)(4). On June 20, 2012 the United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) retained the dairy cow with back tag (b)(4) and gave a retain tag of (b)(4) to the cow. USDA took a surveillance sample and analysis revealed a violative residue in the kidney of 0.11 ppm of ampicillin. FDA has established a tolerance level of 0.05 ppm for residue for penicillin in the uncooked edible tissue of cattle as codified Title 21, Code of Federal Regulations (C.F.R.), Part 556.510. 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 a drug inventory system.
We also found that you adulterated the new animal drug Polyflex Ampicillin for injectable Suspension, NADA 55-030. Specifically, our investigation revealed that you did not use Polyflex Ampicillin as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R. Part 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 and C.F.R. Part 530, including that the use must be by or the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered PolyFlex Ampicillin (PolyFlex Ampicillin for injectable Suspension , NADA55-030) to your dairy cow without following the dose and amount per injection site as stated in the approved labeling. Your extralabel use of PloyFlex Ampicillin Suspension was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. Part 530.11(a). 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, 21U.S.C. § 351(a)(5).
The above is not intended to be an all-conclusive 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 are 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.
FDA acknowledges your firm’s written response, dated December 5, 2012, addressing the observations made during the inspection we conducted at your firm. Your response letter appears to describe correct steps to address the issues of concern. You state in your response you are working on revising treatment protocols to clarify label treatment, proper dosages, route of administration, duration of therapy and withdrawal periods. FDA will need to review your proposed revised treatment protocols and how you plan to implement these records, with any employees.
You should notify this office in writing of the steps you have taken to bring your firm in 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 Matthew Sienko, Compliance Officer, at the address on the letterhead. If you have any questions about this letter, please contact Mr. Sienko at 312-596-4213 or via e-mail at firstname.lastname@example.org.
Scott J. MacIntire
cc: William J. Croatt
Rancho Cantera LLC
2866 N. Sunnyside Rd.
Kent, IL 61044-9605
Illinois Department of Agriculture
Bureau of Animal Health
State Fairgrounds – P.O. Box 19281
Springfield, Illinois 62794-9281
United States Department of Agriculture
Food Safety and Inspection Service
Office of Policy, Programs and Employee Development
1299 Farnam Street, Suite 300
Omaha, Nebraska 68102
Attention: Residue Staff