Milton D. Hilgenkamp
- Hilgenkamp Farm Inc
Arlington, NE 68002
- Issuing Office:
- Kansas City District Office
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Office of Human and Animal Food-
West Division II
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
VIA UNITED PARCEL SERVICE
November 15, 2017
Milton D. Hilgenkamp, Co-Owner
Ronald G. Hilgenkamp, Co-Owner
Hilgenkamp Farms, Inc.
Arlington, NE 68002
Reference: CMS # 539250
Dear Mr. Milton Hilgenkamp and Mr. Ronald Hilgenkamp:
On September 12-14, 2017, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8748 County Road 13, Arlington, Nebraska. 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 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, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the 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 May 24, 2017, you sold a cow identified with ear tag 7691 and bangle tag (b)(4) for slaughter as food. On or about May 24, 2017, (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 desfuroylceftiofur (marker residue for ceftiofur) at 6.691 parts per million (ppm) in the kidney tissue and the presence of flunixin at 0.213 ppm in the liver tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), section 556.113(b)(3)(i) (21 C.F.R. § 556.113(b)(3)(i)). FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver tissues of cattle as codified in 21 C.F.R. § 556.286(b)(1)(i). The presence of these drugs in edible tissue from this animal in amounts above the tolerance 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 drug treatment records. Specifically, on September 12-14, 2017, you were unable to provide treatment records for cow with ear tag 7691. Additionally, your treatment records do not show what condition is treated, dosage, withdrawal times, individual who administered the medication, or route of administration for all medications given. You also failed to maintain an adequate inventory system for determining the quantities of drugs used to medicate your animals which include the list of drugs, quantities, lot numbers, date used or expiration dates. You also failed to segregate treated animals. Specifically, you keep treated animals together in the same pen with non-treated animals. Although leg bands are used, they are removed after meeting milk withholding times. Milk withdrawals are typically shorter than meat withdrawals. A treated animal could be offered for sale before meat withdrawals are met. 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 CeftiFlex® (ANADA 200-420, ceftiofur sodium sterile powder). Specifically, our investigation revealed that you did not use CeftiFlex® 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 lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered CeftiFlex® to cow with ear tag 7691 and bangle tag (b)(4) without following the withdrawal period as stated in the approved labeling. Your extralabel use of CeftiFlex® was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a) and also resulted in illegal drug residues, 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.
We acknowledge receipt of your letter received on October 4, 2017, and in response to the FDA Form 483, Inspectional Observations. However, your response was inadequate to fully address these issues. For example:
- You indicate in the letter only one person, the herdsman, will have access to the drugs and will be allowed to treat animals. In a dairy operation, such as yours, it appears unrealistic to expect one person to be on duty 365 days a year. You do not address how or who will be responsible for drug treatments when he is not on duty.
- You do not indicate that a second person will be monitoring or checking the drug logbook records for accuracy. Also, you do not include the reason for treatment or diagnosis for the animal.
- Regarding communications between the herdsman and hauler: you do not indicate who will be reviewing treatment records and withdrawal times prior to hauling. You also do not include how this review will be documented.
- Regarding your computer system: you do not indicate that this computer system will be reviewed prior to hauling animals to slaughter. You also do not explain safeguards to prevent these electronic records from being altered or the tracking of changes to the data entered.
- Additionally, you do not include any physical separation of animals being treated. During the inspection, you explained how you physically separate animals into a hospital pen and mark them with a colored leg band when animals are under a drug withdrawal period for milk residues. But animals that are under a withdrawal time for meat residues are placed back with the rest of the cows with no such physical separation or markings.
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 Tamara Umscheid, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Dr. Suite 205, Lenexa KS,66214. If you have any questions about this letter, please contact Compliance Officer Umscheid at 913-495-5128 Tamara.Umscheid@fda.hhs.gov
Cheryl A. Bigham
Program Division Director
Office of Human and Animal Foods
Division II West