Inspections, Compliance, Enforcement, and Criminal Investigations
Schlegel Dairy Farms Inc 9/11/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
September 11, 2009
WARNING LETTER CIN-09-68103-17
VIA FEDERAL EXPRESS
Kurt A. Schlegel, Owner
Schlegel Dairy Farms, Inc.
10720 Township Road 526
Shreve, Ohio 44676-9415
Dear Mr. Schlegel:
On May 7, 2009, and June 3, 2009, the U.S Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 10720 Township Road 526, Shreve, Ohio. 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 an animal for slaughter 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.
Specifically, our investigation revealed that on or about October 15, 2008, you sold a Holstein bull veal calf for slaughter as food through (b)(4), where the Holstein bull veal calf was identified with back tag # (b)(4). On or about October 16, 2008, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected on October 16,2008 from this bull veal calf with back tag (b)(4) identified the presence of 0.66 parts per million (ppm) sulfamethoxazole in the liver and 0.70 ppm sulfamethoxazole in the muscle of this animal. The FDA has not established a tolerance for residue associated with use of sulfamethoxazole in the edible tissue of veal calves as codified in Title 21, Code of Federal Regulations (C.F.R.), Part 556 (21 C.F.R. Part 556). The presence of this drug in the edible tissue of this bull veal calf 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).
We also found that you violated section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5), when your employees administered Sulfamethoxazole and Trimethoprim Tablets, 800 milligrams (mg)/160 mg, Double Strength (NDC 61971-120-05) to the bull veal calf. Specifically, our investigation revealed that sulfamethoxazole and trimethoprim tablets were used in an extralabel manner by a layperson on your farm outside the orders, instructions, or supervision of a licensed veterinarian in violation of 21 C.F.R. 530.1 I (a), and the use of these tablets resulted in sulfamethoxazole residue which may present a risk to public health, in violation of 21 C.F.R. 530.11(c).
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 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.
Because the use of the sulfamethoxazole and trimethoprim tablets did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and thus 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 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 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 an update for 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 Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Rabe at 513-679-2700, ext. 163 or firstname.lastname@example.org.
Teresa C. Thompson