A.B. Cole Dairy Farm 19-Apr-08

Department of Health and Human Services	Public Health Service Food and Drug Administration
	PHILADELPHIA DISTRICT 900 U.S. Customhouse 2nd and Chestnut Street Philadelphia, PA 19106 Telephone: 215-597-4390

WARNING LETTER

April 19, 2008

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Chris Cole, Owner
A.B. Cole Dairy Farm
Rural Route 2
Box 329a
Meshoppen, Pennsylvania 18630

Dear Mr. Cole:

An investigation of your dairy operation located at Rural Route 2, Meshoppen, Pennsylvania conducted by a representative of the U.S. Food and Drug Administration (FDA) on November 13 and December 6, 2007, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (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 April 2, 2007, you consigned a bob veal calf identified with back tag [redacted] for slaughter at [redacted] On or about April 3, 2007, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the animal identified the presence of 46.18 parts per million (ppm) sulfamethazine in the muscle tissue and 36.41 ppm sulfamethazine in the liver tissue of the animal. A tolerance of 0.1 ppm has been established for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21,Code of Federal Regulations, Section 556.670 [21 C.F.R. 556.670]. The presence of this drug in the edible tissues of this animal at the reported levels 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)].

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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain treatment records for all of the animals you medicate. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)].

The above is not intended as 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, including 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 written response should be sent to James C. Illuminati, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Compliance Officer, James C. Illuminati, by telephone at 215-717-3078 or via e-mail at jillumin@ora.fda.gov.

Sincerely,

/S/

Thomas D. Gardine
District Director
Philadelphia District

cc: Dr. John I. Enck, Director
Pennsylvania Department of Agriculture
Bureau of Animal Health and Diagnostic Services (BAHDS)
2301 North Cameron Street
Harrisburg, Pennsylvania 17120

Food Safety and Inspection Service (FSIS)
106 South 15th Street, Suite 904
Omaha, Nebraska 68102
Attention: Residue Staff

 

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