Inspections, Compliance, Enforcement, and Criminal Investigations
Wagler Farms 09-May-06
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
Mr. Kenneth L. Wagler
7085 Homestead Road
Morgantown, IN 46160
Dear Mr. Wagler:
An inspection of your dairy. operation located at 7085 Homestead Road, Morgantown, Indiana 46160, conducted by a representative of the Food and Drug Administration (FDA) on November 1418, 2005, confirmed that you offered an animal for sale for slaughter as food that was adulterated under section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Federal Food, Drug, and Cosmetic Act (the Act).You can find the Act and its associated regulations on the Internet through links of FDA's web page at www.fda.gov.
On September 13, 2005, you, sold a bull identified with back tag number 32UP 9127 through [redacted] to [redacted] then delivered the bull to [redacted] where, it was slaughtered for human food use on September 15, 2005. United States Department of Agriculture, Food Safety Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of [redacted] (ppm) gentamicin in the kidney of this bull. No tolerance of gentamicin has been established for residues of gentamicin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (21 C.F.R.), Part 556.300 (21 C.F.R 556.300). In addition, USDA/FSIS analysis of tissue samples collected from this animal identified the presence of [redacted] [which is equal to [redacted]] in the liver of the bull. A tolerance of 125 ppb has been established for residues of flunixin in the liver tissue of cattle as codified in 21 C.F.R. 556.286. The presence of gentamicin and fIunixin in the edible tissues of this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.
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 these violations and to establish procedures whereby such 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 within fifteen (15) working days of receiving this letter, of the specific steps you have taken to correct the noted violations. 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, 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 response should be directed to Ms. Judith Jankowski, Compliance Officer, U.S. Food and Drug Administration at 300 River Place Dr., Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Compliance Officer Jankowski at 313-393-8125.
Joanna M. Givens