Inspections, Compliance, Enforcement, and Criminal Investigations
Aurora Ridge Dairy, LLC 5/10/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New York District|
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
May 10, 2010
WARNING LETTER NYK 2010-14
VIA UNITED PARCEL SERVICE
William J. Cook. Owner
Aurora Ridge Dairy, LLC
2498 Angling Road
Aurora, New York 13026-9749
Dear Mr. Cook:
On November 18, November 20, and December 1,2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle operation located at 2498 Angling Road, Aurora, New York. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
We found that you offered an animal for sale for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the 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 Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the 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 May 18, 2009, you sold a dairy cow, identified with tags (b)(4), for slaughter as food. On or about May 18, 2009, (b)(4) slaughtered this animal. The United States , Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analyses of tissue samples collected from this animal identified the presence of desfuroylceftiofur in the kidney at 0.61 parts per million (ppm). FDA has established a tolerance for residues of ceftiofur in the uncooked edible tissue of cattle at 0.4 ppm, as codified in Title 21, Code of Federal Regulations, Section 556.113 (21 C.F.R. 556.113). The presence of this drug in edible tissue from this animal in this amount 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 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 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 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.
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, 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 Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A. Clark at 716-551-4461, extension 3168.
Ronald M. Pace
New York District