| Public Health Service Food and Drug Administration |
New York District 158-15 Liberty Avenue |
Department of Health and Human Services
February 24, 2011
WARNING LETTER NYK-2011-18
VIA United Parcel Services
Christopher A. and Jessica A. Fredericks, Owners
InSight Dairy, LLC.
682 Newville Road
Little Falls, New York 13365-4614
Dear Mr. and Ms. Fredericks,
On January 4 and 6, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 682 Newville Road, Little Falls, New York 13365-4614. 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 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 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 July 19, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about July 20, 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 12.95 parts per million (ppm) of neomycin residue in the kidney. In addition, our investigation revealed that on or about August 2, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about August 3, 2010, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 10.53 parts per million (ppm) of neomycin residue in the kidney. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430 (21 C.F.R. 556.430). However, this tolerance does not apply to the use of (b)(4) in bob veal calves, and there is no acceptable level of residue associated with the use of this medicated milk replacer in veal calves. 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 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).
We also found that you adulterated the new animal drug neomycin sulfate. Specifically, our investigation revealed that you did not use neomycin sulfate as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a).
Our investigation found that you fed (b)(4) containing neomycin sulfate to both bob veal calves with back tags #(b)(4) without following the approved labeling. The extralabel use of (b)(4)containing neomycin sulfate was in or on feed, in violation of 21 C.F.R. 530.11(b), and the extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because this use of (b)(4) containing neomycin sulfate was not in conformance with the approved labeling, you caused the drug in the feed to be unsafe under section 512(a)(1) of the FD&C Act, 21 U.S.C. § 360b(a)(1), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5). In addition, you caused the animal feed containing the neomycin sulfate to be unsafe under section 512(a)(2) of the FD&C Act, 21 U.S.C. § 360b(a)(2), and adulterated within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6).
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 Dean R. Rugnetta, 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 Dean R. Rugnetta at (716) 541-0324 or Email at Dean.Rugnetta@fda.hhs.gov.
Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District
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