Animal & Veterinary
REGULATORY ACTIVITIES - May/June 2001
FDA Veterinarian Newsletter May/June 2001 Volume XVI, No III
The following firms/individuals received warning letters for offering animals for slaughter that contained illegal drug residues:
- Peter Linssen, Owner, Michigana Farms, Ltd., Scotts, MI
- Roger Masselink, Owner, Roger Masselink Dairy, Middleville, MI
- Peter deVries, General Manager, Royal Farms Dairy, LLC, Garden City, KS
- Gregg Jeffers, Owner, Gregg Jeffers Farm, Poplar Grove, IL
- George Ainger, Co-Owner, Ainger Farm, Harvard, IL
- Jay N. Martin, Owner, Jay N. Martin AKA Horizon Dairy, Clyde, NY
- David C. Footit, Owner, D & K Farm, Middlefield, CT
- Rick L. Gorzeman, Cornerstone Dairy, Tipton, CA
- Michael Hummermeier, Owner, Hummermeier Farm, Pearl City, IL
- Craig Hessenius, Craig Hessenius Farm, Freeport, IL
- Daniel E., Robert F., Thomas A., and John M. Curtin, Partners, Curtin Dairy, LP, Cassville, NY
- George and Gloria Soares, Log Haven Dairy, Hanford, CA
- Frank S. Chaves, Owner, Frank Chaves & Sons Dairy, Lodi, CA
- Grant Van Dyk, Co-Owner, Van Dyk Holsteins, Lynden, WA
- David H. Harris, Harris Livestock, Ashland, OH
- Charles J. Wampler, II, President, Hawk Valley Dairy, Inc., Fulks Run, VA
- Frank Carper, Cranbury, NJ
- Robert H. Klaus, Owner, Robert H. Klaus Farm, Carlinville, IL
- Robert F. Hilmes, Carlyle, IL
- Mervin M. Weaver, Johnsonville, IL
- David B. Hankal, Manager, Kephart Farms, Turlock, CA
- Ralph Vandyk, Owner, Vandyk Dairy, Meridian, ID
- Donald E. Taber, Owner, Donley Farms Inc.
These violations involved illegal residues of gentamicin in a dairy cow; sulfamethoxzole and streptomycin in a bob veal calf; penicillin in cows; oxytetracycline and gentamicin in a cow; gentamicin and penicillin in a cow; streptomycin in a cow; phenylbutazone in a cow; neomycin and sulfadimethoxine in a cow; streptomycin in a horse; sulfamethazine in a hog; penicillin and neomycin in a cow; and neomycin in a heifer calf.
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).
- Arthur E. Bryan, Owner and Operator, Bryan Enterprises, Hanoverton, OH
- Edwin V. Ringer, Co-owner, Hartville Elevator Co., Inc., Hartville, OH
- Denny Hickman, President, Peco Foods, Inc., Tuscaloosa, AL
- John T. Dunbar, President, Champaign Landmark, Inc., Urbana, OH
- Donald and Lucy Hegge, Owners, Rietdyk’s Milling Co., Ridgefield, WA
- Sam C. Shields, Owner, Shields Feed and Supply Co., Coffeeville, AL
- Robert C. Adams, Branch Manager, Western Reserve Farm Cooperative, Middlefield, OH
- John S. Wynkoop, President, Faler Feed Store, Inc., Lithopolis, OH
- Jerry and Helen Stewart, Owners, Stewart’s Farm Supply, Brookville, NY
- Michael S. McCandish, Branch Manager, River Valley Co-Op, Baltimore, OH
- Robert W. Rudy, Vice President, Rudy, Inc., Covington, OH
- William D. Rohrbaugh, General Manager, Medina Landmark, Inc., Medina, OH
- Randall A. Hegenderfer, President, The Centerburg Mill and General Store, Inc., Centerburg, OH
Violations included lack of written procedures for cleaning out or flushing equipment after mixing feeds containing prohibited material; lack of documentation of steps taken to prevent cross-contamination; failure to identify the purchaser of feeds containing animal proteins by name and address; failure to track the use of prohibited materials from processing through distribution; and failure to label finished products with the required cautionary statement "Do Not Feed to Cattle or Other Ruminants."
Lawrence C. Brooks, DVM, Powder Ridge Veterinary Hospital, Middlefield, CT, received a warning letter as a result of an illegal gentamicin residue in a cow offered for sale and slaughter for human food. Dr. Brooks prescribed and dispensed the gentamicin for treatment of the cow’s mastitis. Gentamicin is not approved for use in cattle, and there is no established tolerance for residues of gentamicin in the edible tissues of cattle.
Mr. Jean Michel Lopez, President, Micro Worldwide Trading, Miami, FL, received a warning letter for failure to ensure that imported products meet all requirements of the Federal Food, Drug, and Cosmetic Act. FDA attempted to examine a shipment of Ivomec animal antibiotic offered for entry into the U.S. by Micro Worldwide Trading, and found the entire shipment to be unavailable for FDA examination. The product was not held intact pending receipt of a "Release Notice" from FDA. FDA has requested the U.S. Customs Service to order redelivery of the animal antibiotic which had been distributed without a release from FDA.
Mr. Brian C. Langdon, President, New Decade Laboratories, Inc., Farmington, MN, received a warning letter for several deviations causing veterinary drugs manufactured at this facility to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. Violations included the following:
- manufacturing and cleaning processes had not been validated;
- components, drug product containers, and finished drug products were not properly quarantined and tested;
- batch records lacked complete and accurate information concerning the production and control of drug products; and
- specifications for drug products were incomplete.
Mr. William Prestage, President, Prestage Farms, Inc., Clinton, NC, received a warning letter for violations including failure to conduct potency assays on at least three representative samples of each feed required to be manufactured by his licensed medicated feed mill at periodic intervals during the calendar year 2000, and failure to investigate and correct the cause of medicated feeds that failed assay specifications, and, failure to have master production records.
Mr. Brad Kerbs, President/CEO, Purina Mills, Inc., St. Louis, MO, received a warning letter for the facility located at Oklahoma City, OK, for significant deviations from Current Good Manufacturing Practice (CGMP) regulations for Medicated Feeds, 21 CFR Part 225. Violations included the failure to follow established SOP’s for drug sequencing requirements, failure to conduct the required assays of medicated feeds for drug components, and failure to properly identify bulk drug components in a manner that assures their identity, strength, quality, and purity. In addition, the firm showed a continuing failure to ensure quality control over labeling operations for bagged medicated feeds since June 2000.