| Public Health Service Food and Drug Administration |
| Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139 |
Department of Health and Human Services
WARNING LETTER
2012-DET-01
October 7, 2011
VIA UPS
Mr. Johan J. DeGroot, Owner
Sunshine Dairy
8251 W 200 S
Andrews, Indiana 46702-9714
Dear Mr. DeGroot:
On June 23, and August 12, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8251 W 200 S, Andrews, Indiana 46702-9714. 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 February 22, 2011, you sold a culled dairy cow, identified with back tag (b)(4) ear tag (b)(4) for slaughter as food. On or about February 23, 2011, (b)(4) slaughter this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal on February 23, 2011, identified the presence of 0.06 parts per million (ppm) of penicillin residue in the kidney tissue, 0.145 ppm of sulfadimethoxine residue in the liver tissue, and 0.208 ppm of flunixin residue in the liver tissue. FDA has established tolerances of 0.1 ppm for residues of sulfadimethoxine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.640 (21 C.F.R. 556.640) and 0.125 ppm for residues of flunixin in the liver tissue (target tissue) of cattle as codified in 21 C. F. R. 556.286. The presence of these drugs in edible tissue 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 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 drug flunixin meglumine (Prevail, Injectable Solution, ANADA #200-308). Specifically, the investigation revealed that you did not use flunixin 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 flunixin meglumine injectable solution (ANADA #200-308) to one of your dairy cows identified with back tag #(b)(4) (ear tag (b)(4) without following the route of administration as stated on the veterinarian's prescription labeling. Your extralabel use of flunixin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a) and your extralabel use of flunixin 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. 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.
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 Michael V. Owens, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact Compliance Officer Michael V. Owens at (313) 393-8167 or Email at michael.owens@fda.hhs.gov.
Sincerely yours,
/S/
Glenn T. Bass
District Director
Detroit District Office
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