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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Rusty Knoll Farm, Inc 7/3/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556 
 
 
WARNING LETTER
CMS # 397473
 
 
Via United Parcel Service
 
July 3, 2013
 
Mr. Richard E. Rust, President & Co-Owner
Rusty Knoll Farm, Inc.
58 Rust Road
Gorham, Maine 04038
 
Dear Mr. Rust:
 
On April 19 and 25, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 58 Rust Road, Gorham, Maine 04038. 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 an animal 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 September 17, 2012, you sold a dairy cow, identified with back tag #(b)(4), vaccination ear tag #(b)(4), and farm ear tag #(b)(4) for slaughter as food. On or about September 19, 2012, (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 desfuroylceftiofur, a metabolite of ceftiofur, at 3.71 parts per million (ppm) in the kidney tissue and flunixin at 0.398 ppm in the liver tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113, 21 C.F.R. 556.113 and a tolerance of 0.125 ppm for residues of flunixin in the liver (target tissue) of cattle, as codified at 21 C.F.R. 556.286. The presence of these drugs in edible tissues from this 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 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 drugs (b)(4) (flunixin meglumine, injectable solution, (b)(4)) and (b)(4) (oxytetracycline, injectable solution, (b)(4)). Specifically, our investigation revealed that you did not use (b)(4) as directed by their approved labeling or by the servicing veterinarian’s prescription. Use of these drugs in this manner is an extralabel use. See 21 C.F.R. 530.3(a). 
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C 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 (b)(4) (flunixin meglumine, injectable solution, (b)(4)) to a dairy cow identified with back tag identified with back tag #(b)(4), vaccination ear tag #(b)(4), and farm ear tag #(b)(4), without following the duration of administration and withdrawal period as established by the approved product labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug 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).
 
Our investigation also found that you administered (b)(4) (oxytetracycline, injectable solution, (b)(4)) to your dairy cows without following the established route of administration as stated in the approved product labeling. Your extralabel use (b)(4) (oxytetracycline), injectable solution, (b)(4), was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug 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).
 
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 dated May 13, 2013, was received addressing the observations made during the inspection conducted on April 19 and 25, 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 Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, Massachusetts 02180. If you have any questions about this letter, please contact Compliance Officer Scott M. Loughan at (802) 868-4725 X 109 or email at Scott.Loughan@fda.hhs.gov.
 
 
Sincerely yours,
/S/
CAPT Scott J. Lewis, USPHS
Acting District Director
New England District
 
 
 
cc:       
Alan Rust, Co-Owner
Rusty Knoll Farm, Inc.
58 Rust Road
Gorham, Maine 04038