Inspections, Compliance, Enforcement, and Criminal Investigations
Bella Holsteins, Incorporated 9/13/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Denver District Office|
Building 20 - Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
September 13, 2013
VIA UPS Overnight
Mr. Jerod R. Henrickson
Mr. Gary Henrickson
Bella Holsteins, Inc.
13278 Weld County Road 32
Platteville, Colorado 80651
Ref: # DEN-13-21-WL
Dear Mssrs. Henrickson:
On July 23, 29, and 31, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 13278 Weld County Road 32, Platteville, Colorado. 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 April 4, 2013, you sold a dairy cow, identified with ear tag (b)(4), for slaughter as food. On or about April 4, 2013, (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 1.27 parts per million (ppm) of desfuroylceftiofur in the kidney tissue. FDA has established a tolerance of 0.4 ppm desfuroylceftiofur (marker residue for ceftiofur) in kidney tissue as codified in Title 21, Code of Federal Regulations (CFR), Section 556.113(b)(3)(1) (21 CFR 556.113(b)(3)(1)). The presence of this drug in edible tissues 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 review said records to verify applicable withdrawal time prior to offering the animal for slaughter as food. 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) (ceftiofur sodium, (b)(4)). Specifically, our investigation revealed that you did not use this drug product as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 CFR 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 CFR 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 (b)(4) to a dairy cow, identified with ear tag (b)(4) without following the withdrawal period as stated in the approved labeling. Your extra label use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a) and your extralabel use of the drug product resulted in an illegal drug residue, in violation of 21 CFR 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR 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 that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
Our investigation also revealed that on or about April 4, 2013, Mr. José Cervantes, Hospital Manager at Bella Holsteins, Inc., provided to (b)(4), a signed certification that states that the animals presented for slaughter are clear of all residual drugs. On or about April 4, 2013, you delivered a dairy cow identified with ear tag (b)(4), which contained violative residues of desfuroylceftiofur, to (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
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 Matthew R. Dionne, Compliance Officer, U.S. Food and Drug Administration, 6th Avenue & Kipling Street – Building 20 DFC, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this letter, please contact Compliance Officer Matthew R. Dionne at (303) 236-3045 or email at Matthew.Dionne@fda.hhs.gov.
Ronald K. Jones, D.V.M.
Denver District Manager
PO Box 25387
DFC, Bldg 45
Denver, CO 80225
Mr. John Salazar, Commissioner
Colorado Department of Agriculture
700 Kipling St., Suite 4000
Lakewood, CO 80215