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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activites: Warning Letters December 2008-2009

FDA Veterinarian Newsletter 2008 Volume XXIII, No V

Warning Letter to: Ronald A. Brann, owner, Brann Farms: Lynden, WA
Reason for Letter: Violative drug residues
Date: March 10, 2009

An analysis by the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) of tissue from an animal sold on July 29, 2008, by the firm found penicillin in the kidney at 0.49 parts per million (ppm). FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle. The presence of this drug in the kidney of this animal in an amount exceeding the established tolerance causes the food to be adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act (FFDCA).

An FDA inspection also found that the firm held animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. The firm lacks an adequate system to ensure that animals medicated by the firm have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, the firm failed to maintain treatment records, and it lacks an adequate inventory system for determining the quantity of drugs used to medicate its animals, the Warning Letter said. Food from animals held under such conditions is adulterated within the meaning of the FFDCA.

 

Warning Letter to: Mark V. Porter, owner; Mark V. Porter dba MVP Livestock, Inc.: Sunnyside, WA
Reason for Letter: Violative drug residues
Date: February 11, 2009

During a November 17-18, 2008, inspection of the firm’s operation Grandview, WA, investigators confirmed that cattle sold by the farm contained residues in excess of established safe tolerances. An analysis of tissue from the Holstein dairy cows sold by the firm disclosed flunixin at a level of 1.35 ppm in the liver and 0.046 ppm in muscle from a cow sold in July 2007; penicillin at a level of 0.18 ppm in kidney tissue from a cow sold in January 2008; penicillin at 0.20 ppm in kidney tissue from a cow sold in March 2008; and sulfadimethoxine at 4.66 ppm in liver tissues from a cow sold in April 2008. FDA has established a tolerance of 0.05 ppm for negligible residues of penicillin in the uncooked edible tissues of cattle, a tolerance of 0.1 ppm for negligible residues of sulfadimethoxine in the uncooked edible tissues of cattle, and a tolerance of 0.125 ppm for residues of flunixin in the liver tissue of cattle.

The Warning Letter also said that the firm has animals held under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. The letter said that the firm failed to inquire about the medication status of the animals that it purchased and delivered for sale to a slaughter plant when it delivered the cattle on the dates mentioned. It also failed to maintain treatment records for the animals that had been medicated. Food from animals held under such conditions is adulterated within the meaning of the FFDCA.

 

Warning Letter to: Jean M. Osen, D.V.M., president, Medford Veterinary Clinic: Medford, WI
Reason for Letter: Improper extralabel drug use
Date: February 5, 2009

During an investigation in October 2008, FDA found that the use by a veterinarian employed by the firm of the new animal drug sulfadimethoxine caused the drug to be unsafe and adulterated within the meaning of the FFDCA. For example, the investigation found that the veterinarian used a brand of sulfadimethoxine oral solution to treat a lactating dairy cow in an extralabel manner, but that use is prohibited by regulation. In addition, the firm used a bolus dosage form of sulfadimethoxine to treat mastitis in lactating dairy cattle, which is an extralabel use, also prohibited by regulation.

 

Warning Letter to: Acker Farms, Inc., Randy J. Acker, owner: Waunakee, WI
Reason for Letter: Violative drug residues
Date: January 30, 2009

On or about March 3, 2008, Mr. Acker sold a dairy cow for slaughter that contained flunixin at 1.34 ppm in its liver tissue, and 0.351 ppm in its muscle tissue, according to an analysis by FSIS.

Also, on or about July 25, 2008, a dairy cow consigned by Mr. Acker was slaughtered, and an FSIS analysis of the tissue from the animal found that it contained flunixin at 1.21 ppm in its liver tissue and 0.173 ppm in its muscle tissue. FDA has established a tolerance of 125 parts per billion (ppb) (or 0.125 ppm) in the liver tissue and 25 ppb (or 0.025 ppm) in muscle tissue of cattle. The presence of this drug in edible tissues from these animals in these amounts causes the food to be adulterated within the meaning of the FFDCA.

An FDA investigation found that the firm kept animals under inadequate conditions, failed to maintain complete treatment records so medicated animals bearing potentially harmful drug residues were likely to enter the food supply, and administered drugs extralabely to food producing animals rendering them adulterated.

FDA’s investigation found that the firm administered flunixin meglumine to a dairy cow without following the route of administration as stated in the approved labeling. The extralabel use of flunixin meglumine was not under the supervision of a licensed veterinarian, which is a violation of the regulations covering extralabel drug use in animals. In addition, the firm’s extralabel use of flunixin meglumine resulted in illegal drug residue. In addition, FDA’s investigation found that the firm administered sulfadimethoxine to lactating dairy cows without following the route of administration and animal class as stated in the approved labeling, as well as mixing this drug with oxytetracycline. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by regulation. Mixing oxytetracycline with other drugs is not in accordance with its approved labeling.

Furthermore, FDA’s investigation found that the firm administered neomycin sulfate to lactating dairy cows contrary to the route of administration and animal class set forth in the approved labeling, and did so without the supervision of a licensed veterinarian, in violation of applicable regulations.

Because the firm’s use of these drugs was not in conformance with their approved labeling and did not comply with appropriate regulations, the firm caused the drugs to be unsafe and adulterated within the meaning of the FFDCA.

 

Warning Letter to: Dennis L. Acker: Waunakee, WI
Reason for Letter: Violative drug residues
Date: January 30, 2008

On or about May 19, 2008, Mr. Acker consigned a lot of seven cows and one bull for sale to be slaughtered. On or about May 20, 2008, one of the cows was slaughtered and its liver tissue was found to contain 5.40 parts per million (ppm) sulfadimethoxine, according to an FSIS analysis of the tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the uncooked edible tissue of cattle. The presences of this excess amount in uncooked edible tissue cause the food to be adulterated.

Also, the investigation found that the firm held animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues may enter the food supply. Food from animals held under such conditions is adulterated within the meaning of the FFDCA. FDA said that Mr. Acker’s operation lacks a system to ensure that animals it buys, holds, and then sells for slaughter as food have not been medicated or, if they have been medicated, that the animals are withheld from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues.

 

Warning Letter to: Lodi Veterinary Hospital, Michael S. Etter, D.V.M., president; K.C. Brooks, D.V.M., vice president; Scott T. Pertzborn, D.V.M., secretary-treasurer: Lodi, WI
Reason for Letter: Improper extralabel drug use
Date: January 30, 2009

An investigation conducted by FDA on September 5 and 10, 2008, regarding the use of drugs at the Lodi Veterinary Hospital in Lodi, WI, revealed that veterinarians caused the new animal drug sulfadimethoxine to be unsafe because the drug was used in a manner that did not conform with its approved uses or with the regulations for extralabel drug use in animals.

The firm prescribed and sold sulfadimethoxine to be mixed with oxytetracycline for extralabel use in lactating dairy cows; the firm used sulfadimethoxine oral 12.5% solution, which is not approved for use in lactating dairy cows, and labeled it for intravenous injection after mixing with oxytetracycline. Extralabel use of any sulfonamide drugs in lactating dairy cows is prohibited.

 

Warning Letter to: Dale and Peggy De Grave Farm, Dale A. De Grave, owner: Casco, WI
Reason for Letter: Violative drug residues
Date: January 29, 2009

An FSIS analysis of tissues from a dairy cow Mr. De Grave sold on or about March 11, 2008, slaughter showed that the liver tissue contained flunixin at 0.261 parts per ppm and the presence of sulfamethazine at 29.78 ppm. FDA has established a tolerance of 125 parts per billion (ppb) (or 0.125 ppm) of flunixin in the liver tissue. FDA has not established a tolerance for residues of sulfamethazine in the edible tissues of female dairy cattle 20 months of age or older. The presence of these drugs in edible tissues from this animal in these amounts causes the food to be adulterated.

FDA said in the Warning Letter that its investigation found that the firm kept animals under inadequate conditions, failed to maintain complete treatment records so medicated animals bearing potentially harmful drug residues were likely to enter the food supply, and administered sulfonamide drugs extralabely to food producing animals rendering them adulterated.

 

Warning Letter to: D&D Hawkins Dairy, Inc., Douglas J. Hawkins, co-owner; Dennis Hawkins, co-owner: Chippewa Falls, WI
Reason for Letter: Violative drug residues
Date: January 27, 2009

On or about July 8, 2008, D&D Hawkins Dairy, Inc., sold a veal calf for slaughter as food, and an FSIS analysis found that the calf had desfuroylceftiofur (the marker residue for ceftiofur) at 6.24 ppm in its kidney tissue and the presence of flunixin at 3.17 ppm in its liver tissue. FDA has not established a tolerance for residues of desfuroylceftiofur or flunixin in the edible tissue of veal calves. The presence of these drugs in the edible tissue of this animal causes the food to be adulterated.

FDA said in the Warning Letter that its investigation found that the firm held animals under conditions that are so inadequate that medicated animals bearing potentially harmful drugs residues are likely to enter the food supply. For example, the firm fed discarded milk from cows treated with medications to calves that were intended for slaughter as food.

 

Warning Letter to: Mr. Paul E. Endsley, president, Endsley Dairy Farm, LLC : Hastings, MI
Reason for Letter: Violative drug residues, improper extralabel drug use
Dated: January 5, 2009

An FSIS analysis of tissues from an animal sold by the firm on May 20, 2008, revealed the presence of gentamicin in the kidney. There is no allowable tolerance for gentamicin in cattle. The presence of gentamicin in this animal causes the food to be adulterated within the meaning of the FFDCA.

An FDA investigation also found that the firm held animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, the firm failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of the FFDCA.

FDA’s investigation also found that the firm administered gentamicin to a dairy cow without following the animal class as stated in the approved labeling. That extralabel use of gentamicin was not under the supervision of a licensed veterinarian, which is a violation of the regulations covering extralabel drug use in animals and resulted in an illegal drug residue. Because the use of this drug was not in conformance with its approved labeling and did not comply with the applicable regulations, the firm caused the drug to be unsafe and adulterated under the FFDCA.

 

Warning Letter to: Kidron Auction, Inc., John E. Sprunger, president: Kidron, OH
Reason for Letter: Violative drug residues
Date: December 30, 2008

The firm offered an animal for sale for slaughter as food that was adulterated. On or about February 14, 2008, a calf was consigned for sale at Kidron Auction, Inc., and this calf was later found to be adulterated. An FSIS analysis of the kidney tissue from the animal found that the tissue contained 99.30 ppm of neomycin. FDA has established a tolerance of 7.2 ppm has been established for residues of neomycin in the kidney tissue of cattle. This illegal residue was caused by using a soluble powder containing neomycin sulfate that is not approved for use in veal calves.

Also found in the tissue analysis of this animal were 0.22 ppm sulfamethoxazole and 0.075 ppm flunixin in the liver, and 0.27 ppm sulfamethoxazole and 0.021 ppm flunixin in the muscle. FDA has not established a tolerance for sulfamethoxazole or flunixin residues in edible tissues of veal calves. The presence of these drugs renders the animal adulterated.

FDA’s investigation of Kidron Auction, Inc. found that adulterated animals were sold at auction and that the animals were held under inadequate conditions, which resulted in medicated animals bearing potentially harmful drug residues entering the food supply. Specifically, the firm lacked a system to ensure that animals bought and sold for slaughter as food have not been medicated or, if they are medicated, they have been withheld from slaughter for an appropriate time to deplete the potentially hazardous residues of drugs from edible tissues.

 

Warning Letter to: Todd Troyer: London, OH
Reason for Letter: Violative drug residues
Date: December 22, 2008

An FSIS analysis of tissue samples from a veal calf sold by Todd Troyer on or about February 14, 2008, found 99.30 ppm of neomycin in the kidney tissue. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle. This illegal residue was caused by using a soluble powder containing neomycin sulfate that is not approved for use in veal calves.

In addition, the FSIS analysis of tissue samples collected from this animal identified the presence of 0.22 ppm sulfamethoxazole and 0.075 ppm flunixin in the liver and 0.27 ppm sulfamethoxazole and 0.021 ppm flunixin in the muscle of this animal. FDA has not established a tolerance for sulfamethoxazole of flunixin residues in the edible tissue of veal calves, and the presence of these drugs renders the animal adulterated.

The Warning Letter said that Mr. Troyer had sold an adulterated veal calf for slaughter, held animals under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply, adulterated the new animal drugs neomycin, sulfamethoxazole and flunixin through extralabel use.

 

Warning Letter to: Douglas Bennett Farm; Mr. Douglas Bennett, co-owner: Johnson, VT
Reason for Letter: Violative drug residues
Date: December 5, 2008

An FSIS analysis of tissues from an adult dairy cow that the firm sold on or about February 18, 2008, for slaughter as food found 0.66 ppm of sulfamethazine in the liver and 32.91 ppm in the muscle. The analysis also found detectable levels of gentamicin in the kidney. FDA has not established a tolerance for sulfamethazine in the uncooked edible tissue of adult dairy cows or a tolerance for gentamicin in the uncooked edible tissues of cattle. The presence of these drugs in the edible tissue of the animal caused the food to be adulterated.

The investigation found that the firm held animals under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply, and it adulterated the new animal drug sulfamethazine through extralabel use.

 

Warning Letter to: Erik Martinez, president and chief executive officer, Virbac, Inc.: Fort Worth, TX
Reason for letter: Violations of current Good Manufacturing Practices
Date: December 10, 2008

During an inspection of the firm facilities in Bridgeton, MO, in July 2008, FDA investigators found violations of current Good Manufacturing Practices. The documented violations cause the products to be adulterated under the FFDCA.

In addition, the Warning Letter said that the company had issued promotional material making claims that products were more effective than had been demonstrated by substantial evidence or substantial clinical experience. Therefore, FDA considers the products to be misbranded.

 

Warning Letter to: Carol A. Weyandt, owner, B & C Calves/Livestock: Claysburg, PA
Reason for Letter: Violative drug residues
Date: November 26, 2008

An FSIS analysis of tissues collected from a bob veal calf sold by the firm on or about January 25, 2008, found 15.07 ppm neomycin in the kidney tissue. FDA has not established a tolerance for residues of neomycin in kidney tissue from veal calves, so food from the animal would be considered adulterated under the FFDCA.

 

Warning Letter to: Jose L. Gonzalez, co-owner, Gonzalez Dairy, LLC: Mesquite, NM
Reason for Letter: Violative drug residues, improper extralabel drug use
Date: November 24, 2008

An FSIS analysis of tissue from a Holstein cow sold by the firm on or about July 3, 2008, and slaughtered for food was found to have 10.19 ppm of sulfamethazine in the liver. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the edible tissues of cattle. The presence of the drug in edible tissues causes the animal to be considered adulterated under the FFDCA. The investigation also found that the firm held animals under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply.

In addition, FDA’s investigation found that the firm administered sulfamethazine to a Holstein cow without following the dose and withdrawal times as stated in the approved labeling. Specifically, the firm administered three 32.1-g boluses of a sulfamethazine product per day for 3 consecutive days although the drug label indicated that a 1,000-lb. cow should receive no more than five boluses within a 72-hour period. Also, the label states, “WARNING: Animals intended for human consumption should not be slaughtered for food for at least 12 days after the last dose. Exceeding two consecutive doses may cause violative tissue residues to remain beyond the withdrawal time.” The firm’s extralabel use of sulfamethazine was not under the supervision of a licensed veterinarian, in violation of regulations, and the firm’s extralabel use of sulfamethazine resulted in an illegal drug residue. Because the firm’s use of this drug was not in conformance with its approved labeling and did not comply with applicable regulations, the firm caused the drug to be unsafe and adulterated under the FFDCA.

 

Warning Letter to: John M. Mellott, owner, John Mellott Farm: Mercersburg, PA
Reason for Letter: Violative drug residues
Dated: November 12, 2008

An FSIS analysis of tissue from an animal sold on or about February 14, 2008, for food by the firm was found to contain 8.42 ppm neomycin in the kidney. FDA has established a tolerance 7.2 ppm for residues of neomycin in the kidney of cattle. The presence of neomycin in this amount in the kidney from the animal causes the food to be adulterated under the FFDCA.

An FDA investigation also found that the firm held animals under conditions so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, the Warning Letter said that the firm failed to maintain treatment records. Food from animals held under such conditions is adulterated under the FFDCA.

 

Warning Letter to: Richard E. States: Hesston, PA
Reason for Letter: Violative drug residues
Dated: October 24, 2008

An FSIS analysis of tissue from a bob veal calf sold by Mr. States’ operation on or about April 9, 2008, found flunixin at 0.149 ppm in the liver. FDA has not established a tolerance for residues of flunixin in the edible tissues of veal calves. The presence of flunixin in edible tissues from this animal in this amount causes the food to be adulterated under the FFDCA.

The investigation also found that the firm held animals under conditions so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply. For example, the firm failed to maintain complete treatment records. Food from animals held under such conditions is adulterated under the FFDCA.