Inspections, Compliance, Enforcement, and Criminal Investigations
Windy Ridge Farm 09-Mar-06
Department of Health and Human Services
Public Health Service
New England District
March 9, 2006
RETURN RECEIPT REQUESTED
Mr. Ronald A. Lamarche and Mrs. Yvette Lamarche, Owners
Windy Ridge Farm
259 Ridge Road
Charleston, ME 04422
Dear Mr. and Mrs. Lamarche:
An investigation of your dietary operation located at 259 Ridge Road, Charleston, Maine conducted by a representative of the U.S. Food and Drug Administration (FDA) beginning on November 25, 2005, and ending December 1, 2005, confirmed that you offered an animal for sale for slaughter as food that was adulterated under section 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic (the Act). The inspection also revealed that you caused the new animal drug Flunixin Meglumine and Dihydrostreptomycin Sulfate to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] of the Act and unsafe under section 512 [21 U.S.C. 360b] of the Act. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about October 4, 2005, you consigned a dairy cow, identified with farm tag #769, to [redacted]. The dairy cow was hauled to [redacted] where the dairy cow with farm tag #769 was issued back tag #11EJ9380 [redacted]. The dairy cow was purchased by [redacted] and delivered by a driver contracted by [redacted] on October 4, 2005. On or about October 5, 2005, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.151 parts per million (ppm) of flunixin in the liver tissue and 30.52 ppm of dihydrostreptomycin in the kidney tissue. A tolerance of 0.125 ppm has been established for residues of flunixin in the edible liver tissue of cattle as codified in Title 21, Code of Federal Regulations, Part 556.286 (21 C.F.R. 556.286). A tolerance of 2 ppm has been established for residues of dihydrostreptomycin in the uncooked, edible kidney tissue of cattle as codified in 21 C.F.R. 556.200. The presence of these drugs in edible tissues from this animal in amounts above the respective established tolerances causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [(21 U.S.C. 342(a)(2)(C)(ii)] of the Act.
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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to review treatment records prior to offering an animal for slaughter for human food, and to ensure that appropriate withdrawal times have been observed. Food from animals held under such conditions is adulterated within the meaning
of section 402(a)(4) [21 U.S.C. 342 (a)(4)] of the Act.
In addition, you adulterated the drugs Banamine®, or the generic version, Flunixamine, (Flunixin Meglumine) and the drug Quartermaster® (Dihydrostreptomycin Sulfate) within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] of the Act when you failed to use the drugs in conformance with their approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary human drugs must comply with section 512(a)(4) and 512(a)(5) [21 U.S.C. 360b (a)(4) and 21 U.S.C. 360b(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extra-label use of the drugs Fluxin Meglumine and Dihydrostreotomyxcin Sulfate failed to comply with these requirements. For example, you administered the drug Flunixin Meglumine without following the route of administration set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).You also administered the drug Dihydrostreptomycin Sulfate without the following the route of administration and the withhold time set forth in the approved labeling and you did so with the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in a drug residue above the established tolerance for these drugs, in violation of 21 C.F.R. 530.11(d). Because your extralabel uses of these drugs were not in compliance with 21 CFR Part 530, the drugs were unsafe under section 512(a) [21 U.S.C. 360b(a)] of the Act and your use caused the drugs to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] of the Act.
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 Seth A. Mailhot, Compliance Officer, U.S. Food and Drug Administration, New England District, 1 Montvale Avenue, 4th flood, Stoneham, Massachusetts 02180-3500.
If you have any questions about this letter, please contact Mr. Mailhot by telephone at (781) 596-7769 or by fax at (781) 596-7896.
Gail T. Costello
New England District Office