| Public Health Service Food and Drug Administration |
New England District |
Department of Health and Human ServicesWARNING LETTER
NWE-19-11W
Date: May 20, 2011
Via UPS Next Day Air
Mr. Laurent Bourdeau, Co-Owner
Mrs. Deborah Bourdeau, Co-Owner
Larry Bourdeau/Windy Acres Farm
295 Middle Road
Swanton, Vermont 05488-1093
Dear Mr. and Mrs. Bourdeau:
On April 4 and 7, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 295 Middle Road, Swanton, Vermont. 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 the 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 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 August 2, 2010, you sold a bob veal calf, identified with tag (b)(4) for slaughter as food. On or about August 3, 2010, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of desfuroylceftiofur in the muscle tissue at 2.68 parts per million (ppm), the presence of desfuroylceftiofur in the kidney tissue at 13.53 ppm, and the presence of flunixin in the liver tissue at 13.2 ppm. Additionally, our investigation revealed that on or about December 23, 2010, you sold a bob veal calf identified with tag (b)(4) for slaughter as food. On or about December 24, 2010, (b)(4) slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur in the kidney at 9.47 ppm, and the presence of flunixin in the liver tissue at 2.31 ppm. FDA has established a tolerance of 0.4 ppm in the kidney and 1 ppm in the muscle for residues of desfuroylceftiofur in the edible tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.113 (21 C.F.R. 556.113). FDA has not established a tolerance for residues of flunixin in veal calves. The presence of these drugs in the edible tissues from these animal 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 and you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals. 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 drugs Excenel RTU NADA 140-890 (ceftiofur hydrochloride) and Banamine NADA 101-479 (flunixin meglumine). Specifically, our investigation revealed that you did not use ceftiofur hydrochloride and flunixin meglumine as directed in their approved labeling. Use of these drugs in this manner is an extralabel use. See 21 C.F.R 530.3(a).
The extra label use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered ceftiofur hydrochloride and flunixin meglumine to veal calves with tag (b)(4) and tag (b)(4) without following the animal class as stated in the approved labeling or any written direction by a licensed veterinarian. Your extralabel use of ceftiofur hydrochloride was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel use of ceftiofur hydrochloride resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d). Your extralabel use of flunixin meglumine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
We received your response dated April 18, 2011, and find it to be inadequate. Although you claim in your response that you will implement new plans to keep your treatment and drug inventory records up to date, you have submitted no proof in the form of documents, procedures, logs or inventory records that demonstrate the plans have been implemented.
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, 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 Anthony P. Costello, Compliance Officer, U.S. Food and Drug Administration, 4th Floor, 1 Montvale Avenue, Stoneham, Massachusetts 02180. If you have any questions about this letter, please contact Compliance Officer Anthony Costello at 781 587-7492.
Sincerely yours,
Mutahar S. Shamsi
District Director
New England District
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