Public Health Service
Food and Drug Administration
Kansas City District
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214-1524
Telephone: (913) 495-5100
September 15, 2014
Ref.# CMS 438146
VIA UNITED PARCEL SERVICE
Tony J. Millenkamp, Owner
Pleasant View Dairy
1713 300th Avenue
Dyersville, Iowa 52040
Dear Mr. Millenkamp:
On June 23rd and 24th and August 6th and 11th, 2014, an investigator from the Iowa Department of Agriculture and Land Stewardship, acting on behalf of U.S. Food and Drug Administration (FDA) conducted an investigation of your beef back-grounding and finishing operation located at 1713 300th Avenue, Dyersville, Iowa. 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 foundthat 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 unsafeunder 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 conditionswherebyit may have been renderedinjurious to health.
Specifically, our investigation revealedthat on or about May 1, 2014, you sold a Holstein feeder steer, identified with feedercattle hip tag 749 and back tag(b)(4), for slaughter as food. On or about May 2, 2014, (b)(4), located in(b)(4), slaughtered this animal. United StatesDepartmentof Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue sample collectedfrom this animalidentified the presence of florfenicolin the liver at 5.64 parts per million (ppm). FDA has established a tolerance of 3.7 ppm for residues of florfenicol in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.283 (21 C.F.R. 556.283). 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. 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 Nuflor (florfenicol) Injectable Solution, NADA 141-063. Specifically, our investigation revealed that you did not use Nuflor (florfenicol) Injectable Solution, NADA 141-063, as directed by its approved labeling. 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 Nuflor to a Holstein feeder steer, identified with feeder cattle hip tag749 and back tag (b)(4) without following the withdrawal period as stated in the approved labeling. Your extralabel use of Nuflor 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(d). 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.
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 timeframe within which the connections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to LCDR Jessica E. Hensley, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Dr., Suite 205, Lenexa, Kansas 66214. If you have any questions about this letter, please contact Compliance Officer Hensley at (913) 495-5183 or jessica.hensley@fda. hhs.gov.