Inspections, Compliance, Enforcement, and Criminal Investigations
Three L Farm 12/19/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty AvenueJamaica, NY 11433
December 19, 2013
WARNING LETTER NYK-2014-14
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Gary A. Lashway, Partner
Chad A. Lashway, Partner
Brad J. Lashway, Partner
Three L Farm
882 Irona Road
Ellenburg Depot, New York 12935-3023
Dear Messrs. Lashway:
On September 16, 19 & 26, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 922 Irona Road, Ellenburg Depot, New York. 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 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 March 26, 2013, you sold a bob veal calf, identified with back tag (b)(4) and ear tag (b)(4) for slaughter as food. On or about March 28, 2013, (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 desfuroylceftiofur, a metabolite of ceftiofur, in the kidney tissue, at 11.24 parts per million (ppm) in the kidney tissue.
Further, our investigations revealed that on or about April 10, 2013, you sold a second bob veal calf, identified with ear tags (b)(4) and (b)(4) for slaughter as food. On or about April 12, 2013, (b)(4) slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur at 3.62 ppm in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113, 21 C.F.R. 556.113. The presence of this drug in edible tissue from these animals in these amounts 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 complete 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 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 Ms. Lillian C. Aveta, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Aveta at (718) 662-5576 or by email at Lillian.Aveta@fda.hhs.gov.
Ronald M. Pace
New York District