Hensley, Jimmy A. 9/14/11
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Our Reference: 3008855333
September 14, 2011
Jimmy A. Hensley, Owner
3241 East Tuolumne Road
Turlock, California 95382
Dear Mr. Hensley:
On July 22 and 26, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your calf buying operation located at 3241 East Tuolumne Road, Turlock, California. 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 two animals for slaughter as food that were 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 17, 2011, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about February 17, 2011, (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 neomycin at 20.91 parts per million (ppm) in the kidney tissue. In addition, on or about February 20, 2011, you sold another bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about February 20, 2011, (b)(4) slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of neomycin at 12.02 ppm in the kidney tissue. A tolerance of 7.2 ppm in the kidney has been established for residues of neomycin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.430 (21 C.F.R. 556.430). The presence of this drug in edible tissue from 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 buyer and 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 Darlene Almogela, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, at 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 1114 or via e-mail at Karen.Robles@fda.hhs.gov
Barbara J. Cassens
San Francisco District