Animal & Veterinary
Regulatory Activities - May/June 2004
by Marilyn Broderick, CVM Communications Staff
FDA Veterinarian Newsletter May/June 2004 Volume XIX, No 3
The following individuals and firms received warning letters for offering animals for slaughter that contained illegal tissue residues:
- Dennis Lagler, Owner, Lagler Dairy, Vancouver, Wash.
- Phil Bauer, President, Phillips Cattle Company, Beverly Hills, Calif.
- Robert A. Lofton, Co-Owner, Superior Cattle Feeders LLC, Calipatria, Calif.
- Ronald Hilarides, Manager Partner and Peter Schaafsma, Partner, S & H Dairy, Oakdale, Calif.
- John and Arend J. Bos, Co-Owners, Maple Dairy, Bakersfield, Calif.
- Kevin Finnerty, Epicenter Dairy, Alta Loma, Calif.
- Melvin J. Simoes, Owner, Melvin Simoes Dairy #3, Tulare, Calif.
- Donald Statz, Co-Owner, Statz Farms and Sons, aka Statz Brothers, Inc., Sun Prairie, Wis.
- Edward L. Hoekstra, Managing Partner, Hillcrest Dairy, LLC, Le Grand, Calif.
- Pete and John P. Dykstra, Co-Owners, John Dykstra Dairy, Tulare, Calif.
- Paul J. Wawrzyniak, Owner, Red Creek Farms, Alden, N.Y.
- Frank Kilpatrick, Lewisburg, Tenn.
- Edward M. Ciocca, Owner, Ciocca Dairy, Wendell, Idaho
- Gary De Bruin, Owner, De Bruin Farm, Lynden, Wash.
- John M. Vosters, President, Tidy View Dairy, Inc., Kaukauna, Wis.
- Mike A. Schoneveld, Owner, Country Side Dairy, Ferndale, Wash.
- Lyn F. Main, Owner, Berkshire Valley Holsteins, Copake, N.Y.
- William M. Brinsfield, Jr., Owner, Udder Delight Dairy, Cordova, Md.
The above violations involved penicillin in dairy cows, tilmicosin in a culled beef cow, sulfadimethoxine in culled beef and dairy cows and dairy cows, neomycin in a cow and bob veal calves, flunixin in cows, tetracycline in a cow, and gentamicin in dairy cows.
Warning letters were issued to the following because investigations into illegal tissue residues in animals sold for slaughter as human food revealed serious deviations from the regulations for Extralabel Drug Use in Animals. These deviations caused an animal drug to be used in a manner that was unsafe and adulterated under the Federal Food, Drug and Cosmetic Act.
- Ralph L. Buckel, DVM and Gary R. Hash, DVM, Co-Owners, Chestertown Animal Hospital, Chestertown, Md.
- Richard Wedig, DVM, Co-Owner, Prairie Veterinary Associates, Sun Prairie, Wis.
- Howard S. Warner, DVM, Meredith-Warner Animal Clinic, Lewisburg, Tenn.
- Warning letters were sent to the following individuals and firms for significant deviations form the Current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds.
- Donald E. Orr, Jr., President & General Manager, United Feeds, Inc., Sheridan, Ind.
- Joseph F. Sanderson, Jr., President/CEO, Sanderson Farms, Inc., Laurel, Miss.
Warning letters were received by Thomas S. Hurst, Jr., Owner, Bardstown Mill, Inc., Bardstown, Ky., and Ralph K. Halter, President, Halter Feed & Grain, Inc., Robertsville, Ohio, for significant deviations from the requirements set forth in Title 21 Code of Federal Regulations (CFR), Part 589.2000 – Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). The inspection at Bardstown Mill, Inc. revealed that the firm failed to label feeds or mark the invoice of feeds that contain or may contain prohibited materials with the required cautionary statement “Do Not Feed to Cattle or Other Ruminants.” The inspection at Halter Feed & Grain, Inc., found failure to label products that contain, or may contain prohibited materials with the caution statement; failure to establish and maintain written procedures, including clean-out and flushing procedures to avoid commingling and cross-contamination of common equipment; and failure to maintain records sufficient to track prohibited materials throughout their distribution.
A warning letter was issued to David R. Morris, President, Premium Nutritional Products, Inc., Shawnee, Kan., because an inspection of the own-label animal food distributor operations found a failure to label canned cat food with the cautionary statement “Do Not Feed to Cattle or Other Ruminants” in violation of Title 21 CFR Part 589.2000.