Inspections, Compliance, Enforcement, and Criminal Investigations
Hite's Livestock, Inc. 2/1/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
February 1, 2011
RETURN RECEIPT REQUESTED
Mr. David A. Hite, Owner
Hite’s Livestock, Inc.
HC 34 Box 8
Bloomery, West Virginia 26817-9703
Dear Mr. Hite:
On November 29 and December 3, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your livestock operation located at HC 34 Box 8, Bloomery, West Virginia 26817-9703. 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 August 22, 2010, you sold an unidentified goat for slaughter as food. On or about August 24, 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 moxidectin at 0.0383 parts per million (ppm) in the liver tissue and 0.0543 ppm in the muscle tissue. FDA has not established a tolerance for residues of moxidectin in the edible tissues of goats. 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 lack a system to ensure that animals you buy and then sell for slaughter as food have not been medicated or, if they have been medicated, to allow you to withhold the animals from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues. In addition, you fail to keep accurate records of animals you buy and sell to ensure that the animals can be traced back to the producer or other dealer. 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 violations listed above are not intended to be an all-inclusive list. It is your responsibility to assure that your operations are in compliance with the law. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce, the adulterated animals. As such, you share responsibility for violating the Federal Food, Drug and Cosmetic Act. To avoid future illegal residue violations you should take precautions such as:
1. Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal; and
2. Implementing a system to determine from the source of the animal whether the animal has been medicated and with what drug(s); and
3. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.
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 Ms. Cherlita Honeycutt, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about this letter, please contact Compliance Officer Cherlita Honeycutt at (410) 779-5412 or via e-mail at Cherlita.Honeycut@fda.hhs.gov.