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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Archie Domina Farm 9/13/12

  

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
Phone: (781) 587-7500
    FAX: (781) 587-7556
 


WARNING LETTER
CMS # 336158

 

VIA UPS Next Day Air

September 13, 2012

Archie Domina, Owner
Archie Domina Farm
300 Patterson Road
Franklin, Vermont 05457

Dear Mr. Domina:

On July 3, 5, and 16, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at Clark Road, Sheldon, 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 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 October 13, 2011, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about October 14, 2011, (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 penicillin at 0.32 parts per million (ppm) in the kidney tissue. FDA has not established a tolerance for residues of penicillin in the edible tissues of calves to be processed for veal. The presence of this drug in edible tissues 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 (b)(4) (Penicillin G Procaine) Injectable,(b)(4). Specifically, our investigation revealed that you did not use the (b)(4) (Penicillin G Procaine) Injectable, (b)(4), as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See Title 21, Code of Federal Regulations (C.F.R.), Section 530.3(a) (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) (Penicillin G Procaine) Injectable, (b)(4), to a bob veal calf and heifer calves without following the animal class (that is, not to be used in calves to be processed for veal), dose, frequency of dosing, and route of administration as stated in the approved labeling. Your extralabel use of (b)(4) (Penicillin G Procaine) Injectable, (b)(4), 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 this drug was not in conformance with a licensed veterinarian’s prescribed 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.

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 Anthony P. Costello, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have any questions about this letter please contact Compliance Officer Anthony Costello at (781) 587-7492.

Sincerely,

/S/

Mutahar S. Shamsi
District Director
New England District

CC:


     USDA/FSIS District Office
     Philadelphia, District 60
     Mellon Independence Center
     701 Market Street 2-B South
     Philadelphia, PA 19106


     VT Agency of Agriculture
     116 State Street
     Montpelier, VT  05602