Animal & Veterinary
Regulatory Activities - March/April 2003
by Karen A. Kandra
FDA Veterinarian Newsletter March/April 2003 Volume XVIII, No 2
The following firms/individuals received warning letters for offering animals for slaughter that contained illegal residues:
- Scott Blond, D.V.M., Wyoming, NY
- Charles L. Earsing, Owner, Charles L. Earsing Dairy Farm, Alexander, NY
- John Hoogendam Jr. & Marvin L. Hoogendam, Co-owners, Hoogendam Dairy, Merced, CA
- William M. Walk, Sigel, IL
- John E. Gherty, President and CEO, Land O’Lakes, Inc., St. Paul, MN
- Dimas S. Costa, Darryl J. Azevedo, William J. Carr, Laurence M. Pietrowski, Co-owners, Costa View Farms, Madera, CA
- Peter M. Zacharais, Owner, Zacharias Holsteins, Falmouth, ME
- William M. Vargulick, Owner, William M. Vargulick Dairy Farm
- Eric J. Boersma, Owner, Boersma #2 Dairy, Mira Loma, CA
- James P. Reynolds, Co-owner, Reyncrest Farms, Inc., Corfu, NY
- Gerald R. Vukman, D.V.M., Oakfield, NY
- Antonio Azevedo, Owner, Antonio Azevedo Dairy, Filer, ID
- Robert S. Wilcom, Frederick, MD
- Dale C. Devries and Thomas R. Devries, Owners, Devries Family Farm, LLC, Moxee, WA
- Arthur H. Marquez, Owner, Marquez Dairy, LLC, Chino, CA
- Jose L. Lourenco, Owner, Lourenco Dairy #2; Buhl, ID
The above violations involved illegal residues of flunixin meglumine in two cows; sulfadimethoxine and flunixin in cows; penicillin in a calf; sulfadimethoxine in a beef steer; penicillin in a sow; tetracycline in a cow; gentamicin in a dairy cow; oxytetracycline in a cow; penicillin in a culled dairy cow; flunixin in cow; sulfamethazine in a downer cow; sulfadimethoxine in a cow; sulfadimethoxine in a Holstein cow; and sulfadimethoxine in several culled dairy cows.
A warning letter was issued to William Cramer, Owner, Diamond Pacific, Perris, CA for significant deviations from the current Good Manufacturing Practice (cGMP) regulations for licensed medicated feed manufacturers. Violations included failure to conduct the required number of assays of all medicated feeds containing carbadox, chlortetracycline, sulfathiazole, and penicillin, and other drugs; failure to adequately sequence feeds, including the manufacture of a horse ration after a feed containing monensin which is toxic to equines; failure to maintain production records for the required length of time; and, failure to comply with Veterinary Feed Directive (VFD) requirements.
A warning letter was issued to David G. Hoover, President, Hoover Feed Service, Inc., Goshen, IN, for significant violations of the Federal Food, Drug, and Cosmetic Act, in that the use of the new animal drug in feed manufactured did not conform with an approved New Animal Drug Application as required by section 512 of the Act. The feed mill was found to be manufacturing a medicated feed as a complete feed (Type C) for lactating dairy cattle that is not approved for use in lactating dairy cows.
A warning letter was issued to Nyle A. McAnally, General Manager, McAnally Enterprises LLC, Lakeview, CA, for significant deviations from the current Good Manufacturing Practice (cGMP) regulations for licensed medicated feed manufacturers. Some of the violations included failure to conduct the required number of assays for medicated feeds containing amprolium; failure to compare the actual drug inventory with the theoretical drug inventory; failure to maintain production records for the required length of time; and, use of Type A medicated articles in a manner contrary to their approved labeling.
A warning letter was issued to Paul Ramer, Owner, Paul Ramer Construction, Argos, IN, for causing the adulteration of a new animal drug by continuously feeding medicated feed containing an unapproved animal drug to lactating dairy cows, and offering the milk from those cows for human food.
A warning letter was issued to Charles L. VanderPloeg, President/CEO, Vet Pharm, Inc., Sioux Center, IA, for selling prescription drugs for veterinary use that are adulterated and misbranded. The drugs “Amoxil Amoxicillin for Oral Suspension” and “Sulfamethoxazole and Trimethoprim Oral Suspension USP” among others, are human drugs that were being dispensed for animal use without the required labeling, including adequate directions for use.