Bob Osborn 10/11/11

Department of Health and Human Services	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

WARNING LETTER
2012-DET-02

October 11, 2011

VIA UPS

Robert L. Osborn
3310 South 725 East
Pierceton, Indiana 46562

Mr. Osborn:
 

On July 12 and 26, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation related to an animal which you sold for slaughter as human food on September 15, 2010. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during this investigation. 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. § 360(b). 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 September 15, 2010, you sold a cow, identified with back tag (b)(4)", for slaughter as food. On or about September 18, 2010, (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 gentamicin in the kidney tissue. FDA has not established a tolerance for residues of gentamicin in the edible tissues of cattle. The presence of this drug in the edible tissues of this animal 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 FD&C Act, 21 U.S.C. § 342(a)(4).
 

The above is not intended to be an all-inclusive list of violations. As a producer and hauler 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.

Yom written response should be sent to Tina M. Pawlowski, 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 Pawlowski at (313) 393-8217 or by email at tina.pawlowski@fda.hhs.gov.

Sincerely yours,
/S/
Glenn T. Bass
District Director
Detroit District Office

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