Animal & Veterinary
Regulatory Activities - January/February 2003
by Karen A. Kandra
FDA Veterinarian Newsletter January/February 2003 Volume XVIII, No 1
The following firms/individuals received warning letters for offering animals for slaughter that contained illegal residues:
- Luis M. Bettencourt, Owner, Bettencourt Dairies, Wendell, ID
- Kendall S. Cody, Owner, Cazenovia, NY
- Steve X. Simas, Managing Partner, Lu-Ar Dairy, Hanford, CA
The above violations involved illegal residues of penicillin and sulfadimethoxine in cows; and gentamicin in a cull dairy cow.
A warning letter was issued to Alton J. Hall, D.V.M., President, Natchez Animal Supply Company, Natchez, MS, for significant deviations from Current Good Manufacturing Practice regulations (CGMP) Title 21, Code of Federal Regulations, Part 211, in conjunction with the firm's aquaculture drug repackaging operations, causing the firm's drug, Formalin-F (formaldehyde), to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.
A warning letter was issued to John H. Tyson, CEO, Tyson Foods, Inc., Springdale, AR, for significant deviations from the Current Good Manufacturing Practice (CGMP) regulations for Medicated Feeds (Title 21 Code of Federal Regulations, Part 225). Such deviations included but are not limited to failure to maintain an accurate daily inventory record for each drug used; failure to investigate and implement corrective action for significant discrepancies between actual drug usage and theoretical drug usage; failure to investigate corrective action when production records document the manufacture and shipment of super potent medicated feed; and failure to flush all manufacturing equipment and failure to ensure that the amount of flush material used is adequate to prevent cross-contamination.
A warning letter was issued to Ronald A. Christensen, President and General Manager, Sunnymead Ranch, Inc., Idalou, TX, for significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, 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 the firm manufactures feed for sheep that may contain residues of prohibited material. The sheep feed is mixed in the same equipment that is used for mixing chicken feed containing bovine meat and bone meal. Sheep consuming this feed are ultimately auctioned for sale as food for human consumption.