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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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B & C Calves/Livestock 26-Nov-08

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

Public Health Service
Food and Drug Administration

 

PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106

Telephone: 215-597-4390


WARNING LETTER
09-PHI-04

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

November 26, 2008

Carol A. Weyandt, Owner
B & C Calves/Livestock
RD #2, Box 1240
Claysburg, Pennsylvania 16625

Dear Mrs. Weyandt:

An inspection of your livestock operation located in Claysburg, Pennsylvania, by a U.S. Food and Drug Administration (FDA) investigator on August 11, 2008, confirmed a bob veal-calf purchased and sold by you, an or about January 25, 2008, for slaughter for human food to (b)(4)(b)(4) was in violation of Section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(2)(C)(ii)]. You can find the Act and its associated regulations on the internet through links on FDA's web page at www.fda.gov.

United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissues collected from bob veal calf with back tag (b)(4) disclosed the presence of 15.07 parts per million (ppm) neomycin. in the kidney tissue. FDA has not established a tolerance for residues of neomycin in the kidney tissue of veal calves. The presence of this drug in this amount in the kidney tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act [21 U.S.C. 342(a)(2)(C)(ii)].

(b)(2)

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. The violations listed above are not intended to be an all-inclusive list. It is your responsibility to assure that your operations are in compliance with the law. 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 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 offered an animal for sale to a slaughterhouse that ship in interstate commerce is sufficient to hold you responsible for a violation of the Act.

You should notify this office in writing within fifteen (15) working days of the steps you have taken to bring your firm into compliance with the law. Your response should include each step being taken, 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 Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions regarding this letter, please contact Compliance Officer, Robin M. Rivers at 215-717-3076 or via e-mail at Robin.Rivers@FDA.HHS.GOV.
 

Sincerely,

/S/

Thomas D. Gardine
District Director
Philadelphia District Office

cc: Dr. David R. Griswold, Acting Director
PA Department of Agriculture
Bureau of Animal Health and Diagnostic Services (BAHDS)
2301 North Cameron Street
Harrisburg, PA 17120
United States Department of Agriculture

Food Safety and Inspection Service
Office of Policy, Program and Employee Development
1299 Farnam Street, Suite 300
Omaha, Nebraska 68102
Attention: Residue Staff