Animal & Veterinary
REGULATORY ACTIVITIES - September/October 2002
by Karen A. Kandra
FDA Veterinarian Newsletter 2002 Volume XVI, No V
The following firms/individuals received warning letters for offering animals for slaughter that contained illegal residues:
- Clyde J. Brunner, Co-Owner, Clyde Brunner Farm, New Franken, WI
- Stanley Hall, Owner, Hall & Hall Farm, Limestone, TN
- Tommy D. Carroll, Chuckey, TN
- Bill Lawson, Bill Lawson Livestock, Greeneville, TN
- Chan R. Teel, President, Teel Dairy Farm, Inc., Spokane, WA
The above violations involved illegal residues of gentamicin in cows and neomycin and sulfamethazine in a calf.
A warning letter was issued to Joel G. Newman, President and CEO, United Co-op Farmers, Inc., Fitchburg, MA, for significant deviations from the Current Good Manufacturing Practice regulations for medicated feeds (21 CFR Part 225). This feed manufacturer failed to collect and assay at least three representative samples of medicated feed containing each drug or drug combination used in the establishment at periodic intervals during the calendar year. Although such feeds were produced at this site, no assays were performed in the years 2001 and 2002.
A warning letter was issued to Mark A. Stern, President, Eight In One Pet Products, Inc., Hauppauge, NY, for multiple deviations from the Current Good Manufacturing Practice regulations (21 CFR Part 211), causing drug products, including piperazine citrate syrup for dogs and cats, sulfadimethoxine solution for birds, and aspirin tablets for dogs to be adulterated. Violations included failure to conduct a thorough investigation of unexplained discrepancies or the failure of a batch or any of its components to meet any of its specifications; failure to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process materials and drug products; failure to establish written specifications for active ingredient and excipient components used in drug products; failure to have an individual inventory record of each component and a reconciliation of the use of each lot of such component; failure to maintain a written record of equipment cleaning, maintenance, and use that includes the date and time of usage.
A warning letter was issued to Mrs. Betty L. Mitchell, President, B.L. Mitchell, Inc., Leland, MS, for significant deviations from the Current Good Manufacturing Practice regulations for pharmaceuticals (21 CFR Part 210 and 211). This aquaculture drug repacking operation failed to test incoming bulk iodine disinfectant, nitrofurazone, and container closures to meet product specifications; failed to have a written testing program to assess the stability characteristics of your nitrofurazone products; failure to maintain master packaging and labeling control records; and, failure to establish written procedures for packaging and labeling control or cleaning and maintenance of equipment, including utensils. In addition, their nitrofurazone product does not have the required caution statement "HUMAN WARNING: Carcinogenesis: Nitrofurazone, the acting ingredients have been shown to produce mammary tumors in rats and ovarian tumors in mice. Additionally, some people may be hypersensitive to this product. Either wear gloves when applying, or wash hands afterwards."
A warning letter was issued to Steven Boyum, President, Bombay Elevator, Inc., Kenyon, MN, for causing the adulteration of the animal drugs monensin and chlortetracycline within the meaning of Section 501(a)(5) of the Act when they ordered, purchased, and sold those drugs for use in a manner that does not conform to an approved New Animal Drug Application (NADA) in accordance with Section 512. In addition, they caused the adulteration of animal feed since the formulation and labeling of "Custom Mix for Lambs" failed to conform to an approved NADA. They also supplied false, incomplete, and misleading labeling for the medicated feed, stating the improper manufacturer for the product.