Animal & Veterinary
Regulatory Activities - November/December 2003
by Karen A. Kandra
FDA Veterinarian Newsletter November/December 2003 Volume XVIII, No 6
The following firms/individuals received warning letters for offering animals for slaughter that contained illegal residues:
- Tom R. Milius, President, Wilson C. Milius, Inc., Denver, IA
- Jimmy D. Scarrow, Owner, Scarrow Dairy, Wendell, ID
- Thomas O. Leduc, Co-owner, Green Acre Farm, Champlain, NY
- Joe A. and Kimberly L. Sozinho, Owners, Westside Dairy, Caruthers, CA
- Arie Roeloffs, Co-owner, Southfield Dairy, Wendell, ID
- Bernardus H. Amting, Owner, Amting Dairy Farm, Marshall, MI
- Dennis Dirksen, Maria Stein, OH
- John D. Devereaux, Owner, Prague, OK
- Antonio C. Esteves, Dina M. Esteves, Co-owners, Visalia, CA
- Keith E. Lauer, Owner, R & K Livestock, Texhoma, OK
The above violations involved gentamicin in a culled dairy cow; penicillin in a calf; sulfadimethoxine in a cow; oxytetracycline in cows; penicillin in a dairy cow; gentamicin in a dairy cow; and sulfamethazine in a cow;
A warning letter was issued to Robert S. Kopriva, Senior VP, President & CEO, Sara Lee Foods, Cincinnati, OH, for significant deviations from the Current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds. These violations included inability to verify that batch production records were checked by a responsible individual and storing expired and unlabeled product in the mixing area.
A warning letter was issued to Gloria Donaldson, President, Donaldson & Hasenbein, dba J & R Feed Service, Inc., Cullman, AL, for significant deviations from the cGMP regulations for Medicated Feeds, including failure to properly handle drugs in the mixing area; failure to label all finished feeds; failure to maintain the building in an orderly manner in that water was leaking through a hole in the roof onto raw materials; failure to have a master record file; and, failure of production records to include a written endorsement by a responsible individual.
A warning letter was issued to Francis Guidici, President, LA Heame Company, King City, CA, for significant deviations from the cGMP regulations, including failure to conduct potency assays on representative samples of each feed; failure to assure that all scales and metering devices are tested for accuracy at least once a year; and, failure to prepare and maintain a receipt record for each lot of drug received.
A warning letter was issued to Howard Brown, President, CR Brown Enterprises, Inc., dba CR Brown Feeds, Andrews, NC, for significant deviations from cGMP regulations, including failure to maintain a Master Record File and production records; failure to perform periodic assays for drug components of the medicated feeds whose manufacture requires a medicated feed mill license; and, failure to maintain a daily inventory record for each drug used.
A warning letter was issued to William H. Jenner, President, Lincoln Land Livestock Co., Inc., Mascoutah, IL, 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. The inspection revealed that products that contain or may contain prohibited material fail to bear the caution statement-"Do not feed to cattle or other ruminants."
A warning letter was issued to Patrick M. Hunter, President, H & H Feed & Grain, Inc., Vicksburg, MI, for significant deviations from the requirements relating to animal drugs and medicated feeds, including the Veterinary Feed Directive (VFD) regulations. The investigation revealed that the feed mill was manufacturing complete medicated swine feeds containing the VFD drug, Tilmicosin, in a manner that does not conform to the requirements of the agency's regulations. The feed mill failed to use the Type C medicated feed containing Tilmicosin in accordance with labeled mixing directions, which resulted in sub-potent feeds; failed to follow the product's conditions of use by not feeding continuously for a 21-day period; and, failure to print the cautionary statement "Caution: Federal law limits this drug to use under the professional supervision of a licensed veterinarian. Animal feed bearing or containing this veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian's professional practice," on the VFD medicated feed labeling.
A warning letter was issued to Elton Ray Davis, D.V.M., Owner, Canton Veterinary Clinic, Canton, TX, for dispensing Sterile Penicillin G Procaine in an extra-label manner for two downer cows.
A warning letter was issued to R. Eric Montgomery, President, Oraceutical, LLC, Lee, MA, for selling medicated ear drops with hydrocortisone for veterinary use. These products, "Biotix" and "Clear," are intended for use in the prevention of disease in animals, and they are not covered by an approved new animal drug application, and have not been shown to be safe and effective.
A warning letter was issued to Michael K. Strobush, D.V.M., President/Senior Veterinarian/Co-owner, Grassland Veterinary Service, Granton, WI, for serious deviations from regulations for Extralabel Drug Use in Animals (21 CFR 530), including the compounding and prescribing of sulfamethoxazole and trimethoprim for intramammary infusion to treat mastitis in lactating dairy cattle.