• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Animal & Veterinary

  • Print
  • Share
  • E-mail

Regulatory Activities - September/October 2004

FDA Veterinarian Newsletter September/October 2004 Volume XIX, No V

The following individuals and firms received Warning Letters for offering animals for slaughter that contained illegal tissue residues of animal drugs:

  • M. Troost and Jeff J. Troost, Partners, J Troost Dairy, Chowchilla, CA
  • James W. Jacobs, Owner, Jacobs Ranch L.L.C., Sulphur, OK
  • Joe Nottenkamper, Owner, Beebe, AR
  • José Gregorio Toledo, Owner, -Hatillo, PR
  • Alan D. Vander Horst, Owner, Sierra Dairy, Stephenville, TX
  • George Houser, Owner, Brotherhood Farms, Greenwich, NY
  • Roy Luth, Owner, Roy and Gladice Luth Farm, Harvard, IL
  • Albert Haier, Partner, Beck Farms, LP, Freeville, NY
  • Sid Leyendekker, Hidden Valley Dairy, Mabton, WA
  • Richard M. Nystuen, Owner, Bombay Dairy, Kenyon, MN
  • Geoffrey Vanden Heuvel, Owner, J & D Star Dairy, Chino, CA

The above violations involved penicillin in dairy cows, oxytetracycline in a cow, flunixin meglumine in dairy cows and neomycin in bob veal calves.

A Warning Letter was issued to Richard D. Hansen, DVM, CEO, The Veterinary Pharmacy, Inc., Newcastle, OK, after an inspection of the firm’s process for compounding and distributing single-dose Biobullet® drug products (containing ivermectin or ceftiofur sodium) for use in food producing animals and horses. The inspection documented significant violations of the Federal Food, Drug and Cosmetic Act (FFDCA) and the Animal Medicinal Drug Use Clarification Act and its implementing regulations at Title 21 of the Code of Federal Regulations (CFR) Part 530, Extralabel Drug Use in Animals. The letter said the company’s “compounding using the bulk API (active pharmaceutical ingredient) is not permitted under the Animal Medicinal Drug Use Clarification Act.”

A Warning Letter was issued to Donald E. Hamilton, President/Owner, Illini Feeds, Inc., Aledo, 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 (BSE). The inspection revealed that salvaged pet food containing prohibited material was added as an ingredient to the swine products manufactured at the facility, and the firm failed to label the non-ruminant products with the required cautionary statement, “Do not feed to cattle or other ruminants.”

A Warning Letter was issued to Joel Newman, CEO/President, United Cooperative Farmers, Inc., Fitchburg, MA, for significant deviations from Current Manufacturing Practice (cGMP) regulations for medicated feeds. The deviations include failure to conduct periodic potency assays during the calendar year on at least three representative samples of each feed required to be manufactured by a licensed medicated feed mill, failure to maintain an accurate daily inventory record for each drug used, and failure to accurately indicate the quantity and condition of drugs received on drug receipt records.

A Warning Letter was issued to -Edward Richardson, EdD, Interim President, Auburn University, Auburn, AL, after an FDA inspection was conducted to evaluate the performance of the University as a sponsor of Investigational New Animal Drugs (INADs). The inspection focused on one INAD. Based on the evaluation of the information provided in the documents reviewed in the course of the inspection, FDA concluded the drug sponsored by the University is unsafe under section 512 of the FFDCA and adulterated under section 501(a)(5) because the University did not operate in accordance with the implementing regulations for section 512(j) of FFDCA. The violations included a failure to provide current monitoring and documents with missing and unexplained data. In addition, the University was not aware that it is listed as the sponsor for INADs issued by the Center for Veterinary Medicine. 21 CFR Part 511 contains the requirements for the use of a new animal drug for investigational use under an exemption. The sponsor of the INAD is responsible for adhering to the regulations.

A Warning Letter was sent to Robert A. Collins, President, Impro Products, Inc., Waukon, IA, for marketing several “Whey Blend” products not covered by an approved New Animal Drug Application. The labeling and packaging for these products indicate that they are intended for use, among other things, in the cure, prevention, and treatment of disease in animals and/or to affect the structure or function of their bodies, causing the products to be drugs as defined by the FFDCA.

Clarification

The May/June 2004 issue of FDA Veterinarian contained a description of a Warning Letter issued to a Shawnee, KS, company because the company failed to label food for cats with the cautionary statement, “Do not feed to cattle or other ruminants.” To clarify, FDA does not require such cautionary labels on food for pet cats. However, it does require the cautionary statement on food for exotic zoo cats. The firm -cited in the Warning Letter manufactured food for exotic zoo cats, and therefore was required to label the food with the cautionary statement.