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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities: Warning Letters March-August 2009

FDA Veterinarian Newsletter 2008 Volume XXIII, No VI

WARNING LETTER TO: Glen A. Dykstra, owner, Dyna-Moo Dairy, LLC: Everson, WA
Reason for Letter:
Violative drug residues, improper extralabel drug use
Date: March 24, 2009

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm131719.htm

On or about July 14, 2008, the owner sold a dairy cow for slaughter, which was later found by the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA/FSIS) to have violative residues of the drug penicillin in its kidney tissue. Thus, food from this cow was adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act (FFDCA).

Further investigation by the Food and Drug Administration found that the animals are housed at this operation under inadequate conditions, whereby medicated animals with potentially harmful drug residues are likely to enter the food supply. Thus, food from these animals is adulterated within the meaning of the FFDCA.

The FDA investigation also found that penicillin was used in an extralabel manner and not under the supervision of a licensed veterinarian. Use of the drug in this manner caused it be unsafe and adulterated within the meaning of the FFDCA and resulted in an illegal drug residue.

WARNING LETTER TO: Richard L. and Donald P. Templeton, owners, Templeton Dairy, LLC: Evansville, WI
Reason for Letter:
Violative drug residues
Date: March 27, 2009

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm131716.htm

On or about September 25, 2008, the owners consigned a dairy cow for slaughter, which was later found by the USDA/FSIS to have violative residues of the drug ampicillin in its kidney tissue. Thus, food from this cow was adulterated within the meaning of the FFDCA.

Further investigation by FDA found that the animals are housed at this operation under inadequate conditions, whereby medicated animals with potentially harmful drug residues are likely to enter the food supply. Thus, food from these animals is adulterated within the meaning of the FFDCA.

WARNING LETTER TO: Lyle J. Borkholder, owner, Borkholder Farms: Nappanee, IN
Reason for Letter:
Violative drug residues, improper extralabel drug use
Date: April 22, 2009

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm162793.htm

On or about July 19, 2008, the owner sold a dairy cow for slaughter, which was later found by the USDA/FSIS to have violative residues of the drug sulfadimethoxine in its liver and muscle tissues. Also, on or about September 17, 2008, the owner sold another dairy cow for slaughter, which was later found by the USDA/FSIS to have violative residues of the sulfadimethoxine in its liver tissue. Thus, food from both cows was adulterated within the meaning of the FFDCA.

Further investigation by FDA found that the animals are housed at this operation under inadequate conditions, whereby medicated animals with potentially harmful drug residues are likely to enter the food supply. Thus, food from these animals is adulterated within the meaning of the FFDCA.

The FDA investigation also found that sulfadimethoxine was used in an extralabel manner. The extralabel use of this drug in lactating dairy cows is prohibited by regulation. Further, the owner’s extralabel use of sulfadimethoxine caused it to be unsafe and adulterated within the meaning of the FFDCA and resulted in an illegal drug residue.

WARNING LETTER TO: Alva Carter, Jr., and Allen Carter, co-owners, Carters Milk Factory: Portales, NM
Reason for Letter:
Violative drug residues, improper extralabel drug use
Date: May 19, 2009

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm168471.htm

On or about July 7, 2008, the owners sold a cow for slaughter, which was later found by the USDA/FSIS to have violative residues of the drug flunixin in its liver tissue and the drug desfuroylceftiofur in its kidney tissue. Also, on or about August 13, 2008, the owners sold another cow for slaughter that was later found by the USDA/FSIS to have violative residues of flunixin in its liver tissue. Thus, food from both cows was adulterated within the meaning of the FFDCA.

Further investigation by FDA found that the animals are housed at this operation under inadequate conditions, whereby medicated animals with potentially harmful drug residues are likely to enter the food supply. Thus, food from these animals is adulterated within the meaning of the FFDCA.

The FDA investigation also found that flunixin meglumine and ceftiofur sodium were used in an extralabel manner. Use of both drugs in this manner caused them to be unsafe and adulterated within the meaning of the FFDCA. Further, the owners’ extralabel use of flunixin meglumine resulted in an illegal drug residue.

WARNING LETTER TO: John Dollins, Tom Tune, and Tony Tune, co-owners, Opportunity Dairy: Clovis, NM
Reason for Letter:
Violative drug residues
Date: May 28, 2009

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm168834.htm

On May 12, 2008, the owners sold a cow for slaughter, which was later found by the USDA/FSIS to have violative residues of the drug flunixin in its liver and muscle tissues and the drug sulfadimethoxine in its liver tissue. The owners treated this cow with flunixin and sulfadimethoxine, but could not produce records to show the exact drugs used, how the drugs were administered, any extralabel use of the drugs, and how the meat withdrawal time was calculated. In addition, on July 7, 2008, the owner sold another cow for slaughter, which was later found by the USDA/FSIS to have violative residues of the drug desfuroylceftiofur in its kidney tissue. The owners treated this cow with desfuroylceftiofur, but could not produce any treatment records. Thus, food from both cows was adulterated within the meaning of the FFDCA.

Further FDA investigation found that the animals are housed at this operation under inadequate conditions, whereby medicated animals with potentially harmful drug residues are likely to enter the food supply. Thus, food from these animals is adulterated within the meaning of the FFDCA.

The FDA investigation also found that the owners violated the FFDCA by causing the adulteration of an animal that was sold and subsequently offered for sale to a slaughterhouse that ships in interstate commerce.

WARNING LETTER TO: Beau T. Boles, owner, Boles Livestock: Clovis, NM
Reason for Letter:
Violative drug residues
Date: May 29, 2009

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm168597.htm

On or about the dates of May 13, 2008, July 8, 2008, and August 14, 2008, the owner sold a cow each day for slaughter. The cows were later found by the USDA/FSIS to have violative residues of the following drugs: flunixin (liver and muscle tissues), sulfadimethoxine (liver and muscle tissues), and desfuroylceftiofur (kidney tissue). Thus, food from these cows was adulterated within the meaning of the FFDCA.

Further FDA investigation found that the animals are housed at this operation under inadequate conditions, whereby medicated animals with potentially harmful drug residues are likely to enter the food supply. Thus, food from these animals is adulterated within the meaning of the FFDCA.

WARNING LETTER TO: Newton J. and Darlene A. Reynolds, co-owners, Newton Reynolds Farm: Alberg, VT
Reason for Letter:
Violative drug residues, improper extralabel drug use
Date: May 29, 2009

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm172844.htm

On or about September 22, 2008, the owners sold a dairy cow for slaughter, which was later found by the USDA/FSIS to have violative residues of the drugs flunixin and oxytetracycline in its liver, kidney, and muscle tissues. Thus, food from this cow was adulterated within the meaning of the FFDCA.

Further investigation by FDA found that the animals are housed at this operation under inadequate conditions, whereby medicated animals with potentially harmful drug residues are likely to enter the food supply. Thus, food from these animals is adulterated within the meaning of the FFDCA.

The FDA investigation also found that flunixin and oxytetracycline were used in an extralabel manner and not under the supervision of a licensed veterinarian. Use of both drugs in this manner caused them to be unsafe and adulterated within the meaning of the FFDCA and resulted in illegal drug residues.

WARNING LETTER TO: Orlando Miguel, president, Pet Kiss, Inc.: Palmdale, CA
Reason for Letter:
Marketing of unapproved new animal drug
Date: June 2, 2009

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm165062.htm

On June 2, 2009, the FDA sent Mr. Miguel a letter regarding his firm’s illegal marketing of “Arthritis & Joint Formula” without an approved New Animal Drug Application (NADA). Mr. Miguel’s Web site contained a testimonial statement and other statements indicating that his product is a new animal drug under the meaning of the FFDCA. Within the meaning of the FFDCA, FDA determined that Mr. Miguel’s product is unsafe and adulterated, because it is not the subject of an approved NADA. In addition, Mr. Miguel violated the FFDCA by introducing an adulterated drug into interstate commerce.

WARNING LETTER TO: Gilbert Hurtado, partner, G&H Dairy #1: Twin Falls, ID
Reason for Letter:
Violative drug residues, improper extralabel drug use
Date: July 31, 2009

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm176800.htm

On or about December 1, 2008, Mr. Hurtado sold a dairy cow for slaughter, which was later found by the USDA/FSIS to have violative residues of the drug flunixin in its liver tissue. Thus, food from this cow was adulterated within the meaning of FFDCA.

Further investigation by FDA found that the animals are housed at this operation under inadequate conditions, whereby medicated animals with potentially harmful drug residues are likely to enter the food supply. Thus, food from these animals is adulterated within the meaning of the FFDCA.

The FDA investigation also found that Mr. Hurtado used flunixin in an extralabel manner and not under the supervision of a licensed veterinarian. Use of the drug in this manner caused it to be unsafe and adulterated within the meaning of the FFDCA and resulted in an illegal drug residue.

WARNING LETTER TO: Maurice Loehmer, president, MCAA Land & Cattle, LLC: Monterey, IN
Reason for Letter:
Violative drug residues, improper extralabel drug use
Date: August 19, 2009

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm180922.htm

On or about August 9, 2008, Mr. Loehmer sold a dairy cow for slaughter, which was later found by the USDA/FSIS to have violative residues of the drug sulfadimethoxine in its liver tissue. Thus, the food from this cow was adulterated within the meaning of the FFDCA.

Further investigation by FDA found that the animals are housed at this operation under inadequate conditions, whereby medicated animals with potentially harmful drug residues are likely to enter the food supply. Thus, food from these animals is adulterated within the meaning of the FFDCA.

The FDA investigation also found that Mr. Loehmer used sulfadimethoxine in an extralabel manner and not under the supervision of a licensed veterinarian. Use of the drug in this manner caused it to be unsafe and adulterated within the meaning of the FFDCA and resulted in an illegal drug residue.

WARNING LETTER TO: Jerry and Linda Korle, owners, J&L Dairy: Clarissa, MN
Reason for Letter:
Violative drug residues, improper extralabel drug use
Date: August 28, 2009

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm181496.htm

On or about March 19, 2008, the owners sold a dairy cow for slaughter, which was later found by the USDA/FSIS to have violative residues of the drug procaine G penicillin in its liver tissue. Thus, food from this cow was adulterated within the meaning of FFDCA.

Further investigation by FDA found that the animals are housed at this operation under inadequate conditions, whereby medicated animals with potentially harmful drug residues are likely to enter the food supply. Thus, food from these animals is adulterated within the meaning of the FFDCA.

The FDA investigation also found that the owners used procaine G penicillin in an extralabel manner and not under the supervision of a licensed veterinarian. Use of the drug in this manner caused it to be unsafe and adulterated within the meaning of the FFDCA and resulted in an illegal drug residue.

WARNING LETTER TO: Roger E. Snyder, co-owner and manager, H.G. Early-Snyder Family Farm, LLC: Lexington, KY
Reason for Letter:
Violative drug residues
Date: August 28, 2009

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm181092.htm

On or about October 29, 2008, Mr. Snyder sold a bull at auction, which then entered interstate commerce. After slaughter, the bull was found by the USDA/FSIS to have violative residues of the drug phenylbutazone in its kidney tissue. There is no FDA-established tolerance for residues of phenylbutazone in food from cattle. Thus, food from this bull was adulterated within the meaning of the FFDCA.

Further investigation by FDA found that the animals are housed at this operation under inadequate conditions, whereby medicated animals with potentially harmful drug residues are likely to enter the food supply. Thus, food from these animals is adulterated within the meaning of the FFDCA.