Inspections, Compliance, Enforcement, and Criminal Investigations
HG Early - Snyder Family Farm LLC 8/28/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Cincinnati District Office|
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
August 28, 2009
VIA FEDERAL EXPRESS
WARNING LETTER CIN-09-72883-16
Roger E. Snyder, Co-Owner and Manger
H.G. Early - Snyder Family Farm, L.L.C.
8385 Durbin Lane
Lexington, KY 40515
Dear Mr. Snyder:
On June 18, 2009 a Consumer Safety Officer from the Food and Drug Administration (FDA) completed an inspection of your farm operation located at 8385 Durbin Lane, Lexington, KY 40515. This investigation confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 342(a)(2)(C)(ii) and 342(a)(4)]. You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.
On or about October 29, 2008, you sold a bull through the auction at (b)(4). The bull was subsequently sold in interstate commerce, to (b)(4). On or about October 31, 2008, this animal was slaughtered at (b)(4) United States of Agriculture, Feed Safety and Inspection Service (USDA/FSIS), analyses of tissue samples collected from this bull identified the presence of:
|Phenylbutazone||Kidney||Not determined||No Tolerance Established|
There is no established tolerance for residues of phenylbutazone in the uncooked edible tissues of cattle codified in Title 21, Code of Federal Regulations, section 556 (21 CFR 556). The presence of this drug in uncooked edible tissues from this animal 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)].
Our investigation found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues may enter the food supply. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)]. You lack a system to ensure that animals you buy, hold, 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. Further, you do not have an inventory system that would enable you to reconcile the quantity of drugs purchased with the quantity of drugs administered.
You should take prompt action to correct the above 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.
The above is not intended to be an all-inclusive list of violations. It is your responsibility to ensure that your operations are in compliance with the law. As a buyer and seller of animals intended for slaughter as food, you are frequently the individual who introduces or offers for introduction into interstate commerce the adulterated animal. As such, you share the responsibility for violating the Federal Food, Drug, and Cosmetic Act. To avoid future illegal residue violations, you should take precautions such as implementing a system or systems to determine and record the source of the animal, to determine whether the animal has been medicated and with what drug(s), and to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue.
You should notify this office in writing within 15 working days of the steps you have taken to bring your firm into compliance with the law. Your response should include each step being taken, that has been taken, or will be taken to correct the violations and to prevent their recurrence. If corrective action cannot be completed within IS 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 written response should be sent to Stephen J. Rabe, Compliance Officer, at the address located on the letterhead. If you have any questions about this letter, please contact Mr. Rabe at (513) 679-2700 ext 163.
Teresa C. Thompson