Animal & Veterinary
REGULATORY ACTIVITIES - September/October 2001
FDA Veterinarian Newsletter September/October 2001 Volume XVI, No V
The following firms/individuals received warning letters for offering animals for slaughter that contained illegal drug residues:
- Michael L. Williams, President, Williams Cattle Co., Inc., London, KY
- J. Kenneth Fussell, Burns, TN
- Delmar Van Dam, Owner, High Desert Dairy, Lancaster, CA
- Maria Silveira, Owner, Silveira Dairy, Escalon, CA
- Richard A. Edwards, President, Oakland View Farms, Ridgely, MD
- John S. Leal, Adelino Ormonde, & Edward Ormonde, Partners, O & L Dairy #2, Tulare, CA
- Robert J. Sturm, Vice President, J-Rob Farms, Inc., Caledonia, NY
These violations involved illegal residues of penicillin, sulfamethazine, sulfadimethoxine, and sulfamethoxazole in dairy cows, and neomycin in calves.
Follow-up inspections revealed that Mr. Williams lacked controls to prevent the purchase and sale of animals adulterated with drug residues.
Mr. Fussell was found to be adulterating the drug Pfizer Pen BP-48, Sterile Penicillin G Benzathine and Penicillin G Procaine in aqueous suspension, because he was using the drug at higher than labeled dosages and without following labeled withdrawal times.
Mr. Van Dam was found to hold animals under improper conditions whereby diseased animals and/or medicated animals bearing potentially harmful drug residues are likely to enter the food supply.
Ms. Silveira was found to be adulterating the drug Mutual Pharmaceutical brand of sulfamethoxazole and trimethoprim tablets, since she did not follow her veterinarian's prescribed withdrawal time of thirty days prior to slaughter.
Mr. Edwards did not properly identify treated animals to assure they are not sold for slaughter, did not maintain treatment records, and he did not follow labeling directions for medicated feed.
O & L Dairy was found to lack an adequate system for determining the medication status of animals offered for slaughter, and for assuring that animals which had been medicated had been withheld from slaughter for the appropriate periods of time to deplete potentially hazardous residues of drugs.
Mr. Sturm was found to hold animals on his farm under conditions that are so inadequate that diseased animals and/or medicated animals bearing potentially harmful drug residues are likely to enter the food supply. In addition, he failed to use the drug, Albon, containing sulfadimethoxine, in conformance with the labeling.
A warning letter was issued to the following firms for violations related to 21 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).
- Scott Nelson, Owner, Integra Fish Foods, Inc., Grand Junction, CO
- Bruce A. Burgett, General Manager, The Carrollton Farmers Exchange, Carrollton, OH
Violations included failure to label feeds that contain, or may contain, prohibited materials with the required cautionary statement "Do Not Feed to Cattle or Other Ruminants," insufficient customer records to track the distribution of products, and lack of written procedures for cleaning or flushing equipment after mixing feeds containing prohibited material.
Robert Kofkoff, President, Kofkoff Egg Farms, LLC, Bozrah, CT, received a warning letter for significant deviations from the Current Good Manufacturing Practice Regulations (GMP's). Mr. Kofkoff was cited for failure to conduct adequate clean-out procedures which could result in unsafe contamination of the finished product, and for the manufacture of a medicated feed for replacement chickens that is not approved for such use.
John C. Gale, Chief Executive Officer and Rajiv Lall, President, Vets Plus, Inc., Knapp, WI, received a warning letter for violations of GMP's in that products listed in their product catalogs are marketed with therapeutic claims and without proper approvals. These products include AGRI PLUS Calcium Drench, Vets Plus Cal-C-Fresh, AGRI PLUS CMPK with D3 Drench, Vets Plus Keto-Nia Fresh, and HORSES Prefer BIO-HOOF.