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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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McGovern Farm, Inc 6/28/12

  

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
(781) 587-7500
FAX: (781) 587-7556 

WARNING LETTER
CMS # 318279

VIA UPS Next Day Air

June 28, 2012

Mr. Hugh E. McGovern
Owner
McGovern Farm, Inc.
383 Main Street
Dunstable, MA 01827-1804

Dear Mr. McGovern:

An investigation of your operation located in Dunstable, MA, by a Food and Drug Administration investigator on April 23 – June 08, 2012 confirmed a cow purchased and sold by you on or about July 26, 2011, for slaughter for human food to (b)(4), was in violation of Section 402 (a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). 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.

Specifically, our investigation revealed that on or about July 26, 2011, you sold a cow, identified with state back tag (b)(4) for slaughter as food. On or about July 27, 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 0.47 parts per million (ppm) of Desfuoylceftiofur in the kidney tissue, and the presence of 0.153 ppm of Sulfadimethoxine in the liver tissue and 0.15 ppm in the muscle. FDA has established a tolerance of 0.4 ppm for residues of Desfuoylceftiofur in the kidney tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.113(b) [21 C.F.R. 556.113(b)]. FDA has established a tolerance of 0.1 ppm of Sulfadimethoxine in the liver tissue and muscle of cattle as codified in Title 21, Code of Federal Regulations, Section 556.640(b) [21 C.F.R. 556.640(b)]. The presence of these drugs in edible tissue from this animal in these amounts cause 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).

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. The violations listed above are not intended to be an all-inclusive list. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce, the adulterated animal. As such, you share the responsibility for violating the Federal Food, Drug and Cosmetic Act. To avoid future illegal residue violations you should take precautions such as:

1. Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal;
2. Implementing a system to determine from the source of the animal whether the animal has been medicated and with what drug(s); and
3. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.

You should be aware that it is not necessary for you to have personally shipped an animal in interstate commerce to be responsible for a violation of the Act. The fact that you offer animals for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.

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 Karen Archdeacon, 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 Karen Archdeacon at (781) 587-7491 or Email at karen.archdeacon@fda.hhs.gov.
 

Sincerely,

/S/

Mutahar S. Shamsi
District Director
New England District