Sprague Ranch, LLC 11/18/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
CMS # 411867
VIA UPS Next Day Air
November 18, 2013
John Keith Sprague, III, Co-Owner
Chelsea Sprague, Co-Owner
Sprague Ranch, LLC
6907 VT Route 14
Brookfield, VT 05036-9511
Dear Sir and Madam:
On July 26, 2013 and August 27, 2013 the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 6907 VT Route 14, Brookfield, VT. 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 the dates listed in the table below you sold two dairy cows for slaughter as food. One of the animals was slaughtered by (b)(4) and the other was slaughtered by (b)(4). As described in the table below, the United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS), analysis of tissue samples collected from these two animals identified the presence of drugs in the edible tissues in which illegal residues were reported.
Farm Ear Tag
Back Tag (b)(4)
FDA has established a tolerance of 0.4 parts per million (ppm) for residues of desfuroylceftiofur in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, Section 556.113(b)(3) (21 C.F.R. 556.113(b)(3)). The presence of this drug in edible kidney 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.
FDA acknowledges the written response we received following our inspection. A letter received on October 3, 2013, was received addressing the observations made during the inspection conducted on July 26, 2013 and August 27, 2013. Although your letter indicates that you have taken steps to address our observations, we find that it is inadequate to address all of the violations noted above.
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 the Food and Drug Administration, Attention: Scott M. Loughan, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 802-868-4725 x 109.
Amber G. Wardwell
Acting District Director
New England District
Kristin Haas, D.V.M., Director (Purged)
Division of Food Safety and Consumer Protection
Vermont Agency of Agriculture
116 State Street
Montpelier, Vermont 05620
Susan Scarcia (Purged)
Deputy District Manager
USDA Philadelphia, District 60
Mellon Independence Center
701 Market Street 2-B South
Philadelphia, Pennsylvania 19106