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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Fairmont Farm Inc. 09-Mar-07

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

Public Health Service
Food and Drug Administration

 

New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896




WARNING LETTER
NWE-10-07W

VIA FEDERAL EXPRESS

March 9, 2007

Richard H. Hall, Co-Owner
Fairmont Farm Inc.
95 Lyle Young Road
East Montpelier, VT 05651

Dear Mr. Hall:

An investigation of your dairy operation located at 95 Lyle Young Road, East Montpelier, Vermont conducted by a representative of the U.S. Food and Drug Administration (FDA) on December 5, 2006 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)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (the Act). The investigation also revealed that you caused the new animal drug Penicillin G procaine to be adulterated within Section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act and unsafe under section 512(a) [21 U.S.C. § 360b(a)] 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 September 25, 2006 a dairy cow from your farm identified with back tag 16JX9327 and farm tag, 6305 was picked up and transported to cattle dealer [redacted]. The cow was sold the same day to [redacted] or slaughter as food. The United States Department of Agriculture, Food Safety an Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal on September 26, 2006 identified the presence of 0.14 parts per million (ppm) of penicillin in the kidney tissue of the cow. A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle as codified in the Title 21, Code of Federal Regulations, Section 556.510 (21 C.F.R. 556.510). The presence of this drug in this amount in uncooked edible tissues from this animal causes the food to be adulterated within the meaning or 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.

In addition, you adulterated penicillin G procaine within the meaning of Section 501(a)(5) [21 U.S.C. 351 (a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extra-label 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 extra-label use of approved veterinary or human drugs must comply with Sections 512(a)(4) and 512(a)(5) [21 U.S.C. § 360(a)(4) and 21 U.S.C. § 360(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extra-label use of penicillin G procaine failed to comply with these requirements.

For example, you administered penicillin G procaine without following the dosage level and duration of treatment for cattle 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). Furthermore, your extra-label use resulted in an illegal drug residue, in violation of 21 C.F.R. §530.11(d). Because your extra-label use of this drug was not in compliance with 21 C.F.R. Part 530, the drug was unsafe under Section 512(a) [21 U.S.C 360 (a)] of the Act and your use caused it 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 violation and prevent its 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 reply should be directed to Anthony P. Costello, Compliance Officer, 1 Montvale Avenue, Stoneham, MA 02180. If you have any questions you can contact Mr. Costello at 781 596-7716.

Sincerely,

/S/

Gail T. Costello
District Director
New England District Office

cc:
Julie A. Cornett, D.V.M.
Senior Veterinary Officer
Technical Assistance/Correlation US Department of Agriculture Food Safety and Inspection Service
Technical Service Center Landmark Center
1299 Farnam Street
Omaha, NE 68102

Carl Cushing
Director
State of Vermont, Department of Agriculture
116 State Street
Draw 20
Montpelier, VT 05620

Bonnie Hall
95 Lyle Young Road
East Montpelier, VT 05652

David Tucker Purchase
224 Echo Hill Road
Craftsbury, VT 05826