North Florida Holsteins, LLC. 3/28/14
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
w/ DELIVERY CONFIRMATION
March 28, 2014
Mr. Donald T. Bennick, Owner
North Florida Holsteins, LLC
2740 West County Road 232
Bell, Florida 32619-1350
Dear Mr. Bennick:
On January 7, 8, 9 and 10, 2014, the Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 2740 West County Road 232, Bell, Florida. This letter notifies you of 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 August 20, 2013, you sold a dairy cow identified with back tag (b)(4) (ear tag (b)(4)) for slaughter as food. On or about August 21, 2013, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service’s (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur (marker residue for ceftiofur) at 1.77 parts per million (ppm) in the kidney. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Part 556.113(b)(3)(i) (21 C.F.R. 556.113(b)(3)(i)). The presence of this drug in edible tissues from this animal in these amounts 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 Excede® (ceftiofur crystalline free acid sterile suspension, NADA 141-209). Specifically, our investigation revealed that you did not use Excede® 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. 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 Excede® to a dairy cow with back tag (b)(4) (ear tag (b)(4)) without following duration of the treatment as stated in its approved labeling or veterinary prescription. Your extralabel use of Excede® was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of Excede® resulted in an illegal drug 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. 530, you caused this 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 are in compliance with the law.
You should take prompt action to correct the violations described in this letter and 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.
We received your written response to the Form FDA 483 List of Observations issued to your firm on January 10, 2014, in our office on January 23, 2014. We acknowledge that you stated you have retrained your animal health technicians in proper computer data entry; however you did not include any training records to verify this corrective action. With respect to Observation #2, you state that as a result of this incident the complete records for all cows being sold for slaughter are now thoroughly reviewed before a cow is considered for sale. You stated in your response that you will develop a drug/supply warehouse to better control the inventory of drugs held at your dairy.
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 timeframe 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 Carla Norris, Compliance Officer, at the address on this letterhead. If you have any questions about this letter, please contact Ms. Norris at (407)-475-4730.
Kathleen M. Sinninger
Acting Director, Florida District