Inspections, Compliance, Enforcement, and Criminal Investigations
Acker, Randy J. 1/30/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7132
FAX: (612) 334-4142
January 30, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 09 - 08
Randy J. Acker
Acker Farms, Inc.
4884 Highwood Circle
Middleton, Wisconsin 53562
Dear Mr. Acker:
On August 25 and September 12, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5000 Pheasant Branch Road, Middleton, Wisconsin. 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 FDA's web page at www.fda.gov.
We found that you offered for sale animals for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the 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 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 March 3, 2008, you sold a dairy cow identified with your farm tag [(b)(4)] for slaughter as food. On or about March 3, 2008, [(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 flunixin at 1.34 parts per million (ppm) in liver tissue, and 0.351 ppm in muscle tissue.
In addition, our investigation revealed that on or about July 24, 2008, you consigned a dairy cow, identified with your farm tag [(b)(4)] for sale through [(b)(4)] On or about Ju1y 25 2008, [(b)(4)] slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of flunixin at 1.21 ppm in liver tissue and 0.173 ppm in muscle tissue. FDA has established a tolerance of 125 parts per billion (ppb)(0.125 ppm) in liver tissue and 25 ppb (0.025 ppm) in muscle tissue of cattle as codified in 21 CFR 556.286(b)(1).
The presence of this drug in, edible tissues from these animals in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the 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 Act, 21 U.S.C. § 342(a)(4).
We also found that you adulterated the new animal drugs flunixin meglumine, sulfadimethoxine, oxytetracycline, and neomycin sulfate. Specifically, our investigation revealed that you do not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use, 21 CFR 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 CFR 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 flunixin meglumine to a dairy cow without following the route of administration as stated in the approved labeling. Your extralabel use of flunixin meglumine was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use of flunixin meglumine resulted in illegal drug residue, in violation of 21 CFR 530.11(d). In addition, our investigation found that you administer sulfadimethoxine to lactating dairy cows without following, the route of administration and animal class as stated in the approved labeling, as well as mixing this drug with oxytetracycline. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 CFR 530.41(a)(9). Mixing oxytetracycline with other drugs is not in accordance with its approved labeling. Furthermore, our investigation found that you administer neomycin sulfate to lactating dairy cows contrary to the route of administration and animal class set forth in the approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 CFR 530, you caused the drugs to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the 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 animal's 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.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 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 Dr. Brian D. Garthwaite, Compliance Officer, U.S. Food and Drug Administration, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.
W. Charles Becoat