Animal & Veterinary
REGULATORY ACTIVITIES - November/December 2001
FDA Veterinarian Newsletter November/December 2001 Volume XVI, No VI
by Karen A. Kandra
The following firms/individuals received warning letters for offering animals for slaughter that contained illegal drug residues:
- James Schairer, President, James Schairer Farms, Inc., Birnamwood, WI
- Thomas E. Longhenry, Owner, Longhenry Farms, Glencoe, MN
- Thomas Paskewitz, Co-owner, Paskewitz Cattle Co., Vesta, MN
- Hugh C. Cox, Owner, Hugh Cox Livestock, Calhoun, GA
These violations involved illegal residues of gentamicin in a cow; tilmicosin and phenylbutazone in a dairy cow; and, penicillin in dairy cows.
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).
- Barrie or James Wilcox, Co-Presidents, Wilcox Farms, Inc., Roy, WA
- William W. Himmelspach, Owner, Tualatin, OR
- Charles A. Holdren, CEO/President, Agri-Mark Farmers Co-op, Inc.
- Mark W. Roesner, Owner/President, Copley Feed & Supply, Copley, OH
- Barbara J. Hinton, President, The Hyland Co., Inc., Ashland, KY
- Terry R. Renner, President, F.W. Renner & Sons, Inc., Canton, OH
Violations included failure to establish a written system, including clean-out and flushing procedures to avoid commingling and cross-contamination of common equipment; failure to separate the receipt, processing, and storage of the product containing prohibited material from non-prohibited material; failure to maintain records sufficient to track the materials throughout the receipt, processing, and distribution of products; failure to label products with the required cautionary statement "Do No Feed to Cattle or Other Ruminants."
Marvin L. Goldberg, President, Equirace Health and Speed Products, Washington, PA, received a warning letter for distributing prescription veterinary and human drugs to lay persons without a lawful order from a licensed veterinarian who has a valid veterinarian-client-patient relationship with his/her customers. In addition, certain prescription veterinary and human drugs offered for sale by Equirace are adulterated within the meaning of Section 501(a)(5) of the Act in that they are new animal drugs that are unsafe within the meaning of Section 512(a)(1)(A) because there are no approved applications filed pursuant to Section 512(b) for their use in horses.
The following drugs are not approved for use in horses: methocarbamol tablets; Bactrim (sulfamethoxazole/trimethoprim) tablets; isoxsuprine tablets; Baytril (enrofloxacin) injection; and Naquasone (dexamethasone/ trichlormethiazide) bolus. Likewise, these drugs are misbranded within the meaning of Section 502(f)(1) of the Act in that their labeling does not contain adequate directions for use of these drugs in horses.
The inspection revealed that a partner at Equirace, Franklin Pellegrini, D.V.M., is a licensed veterinarian, however, he does not have a valid veterinarian-client-patient relationship with any of Equirace's customers. Further, the inspection found that Dr. Pellegrini's role at Equirace is not to dispense medication in his capacity as a licensed veterinarian, but to act as a consultant should a customer have questions about the drugs he or she is purchasing.
John W. Peters, General Manager, Thomas Products LLC, Madera, CA, received a warning letter for significant deviations from Current Good Manufacturing Practice (CGMP) regulations for medicated feeds. Violations included failure to perform three assays for Amprol 25% (amprolium), failure to sequence, flush, or physically clean the manufacturing and delivery equipment between batches of medicated feed to ensure that cross-contamination does not occur; failure to maintain a daily theoretical drug inventory of Type A medicated articles; and, failure to provide adequate directions for use for medicated feeds sold by the firm.
John Swisher, Owner/CEO, United Feeds, Inc., Sheridan, IN, received a warning letter for selling and shipping a Category II Type A Medicated Article to a customer lacking a valid FDA Medicated Feed Mill License. In addition, several deviations from CGMP's were found, such as, failure to perform a follow-up investigation of an out-of-limits assay, i.e., super-potent penicillin; failure to clean scoops used to handle Medicated Articles; failure to prevent dust on drug component bags; and, heavy accumulation of dust on floor, bulk containers and shelves in the component storage and mix areas.