Animal & Veterinary
REGULATORY ACTIVITIES - July/August 2001
FDA Veterinarian Newsletter July/August 2001 Volume XVI, No IV
The following firms/individuals received warning letters for offering animals for slaughter that contained illegal drug residues:
- Joe A. Meneses, Partner, Areias & Meneses Dairy, Fresno, CA
- Carlyn A. Jensen, Owner, Jensen Dairy, Hanford, CA
- E. Manuel Costa, Owner, C & C Holsteins, Hanford, CA
These violations involved illegal residues of penicillin in dairy cows. Follow-up inspections revealed lack of adequate systems for determining the medication status of animals offered for slaughter, for assuring that medicated animals have been withheld from slaughter for appropriate periods of time to deplete hazardous residues of drugs, for assuring that drugs are used in a manner consistent with the directions contained in their labeling, and for determining the quantities of drugs used to medicate animals. In addition, Mr. Meneses was found to be adulterating the drug Agri-Cillin brand Penicillin G Procaine Injectable Suspension, by administering one 40 ml injection per day at one site, resulting in an overdose, and likely causing the illegal residues found in the animal consigned for slaughter.
Mr. Jensen was found to be adulterating the drug Pfi-Pen G by administering one 50 ml injection per day at one site. He also used Tylan 200, which is not approved for use in lactating dairy cattle.
Mr. Costa was found to be adulterating the drug Agri-Cillin by administering a mixture of 30 ml of water with 30 ml of Agri-Cillin to prepare a uterine infusion to medicate his lactating cattle. In addition, Mr. Costa has a history of offering five (5) animals for sale for human food which have been found to be adulterated with drug residues between 1993 and 1996.
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).
- Matt Geib, Owner, Greeley Elevator Company, Greeley, CO
- Brian J. Raymond, Owner, Sandy Lake Mills, Sandy Lake, PA
- Eugene P. Yachere, Owner, Yachere Feed, Rockwood, PA
- Michael Bensman, President, Minster Farmers Cooperative Exchange, Inc., Minster, OH
- Richard A. Warren, Manager, Perry Coal and Feed Co., Perry, OH
- Alan R. Beckwith, General Manager, Jefferson Milling Co., Jefferson, OH
- Gary E. Berrier, Owner, Dorset Milling, Dorset, OH
- Jeffrey Ettinger, President, Earl B. Olson Feed Mill, Willmar, MN
- James A. Bose, President, Lime Creek Ag Services, Inc., Fulda, MN
- Kenneth H. Sherwood, President, Alaska Garden and Pet Supply, Inc., Anchorage, AK
- Dale L. Danielson, Manager, Adrian Elevator, Inc., Butterfield, MN
- Jerry M. Behimer, President, Material Resources, LLC _ Gateway Co-Packing Company, Washington Park, IL
- Dr. F. Abel Ponce de Leon, Chair, Department of Animal Science, University of Minnesota, St. Paul, MN
- Robert E. Rahrig, General Manager, Countryline Co-Op, Inc., Pemberville, OH
- Reid Kooch, President, Wallowa County Grain Growers, Inc., Enterprise, OR
- Karl T. Kule, Co-Owner, Valley Feed Mill, Inc., Orwell, OH
- Thomas Bostic, General Manager, Central Ohio Farmers Cooperative, Inc., Marion, OH
Violations included lack of written procedures for clean-out of the feed mixer; lack of records sufficient to track materials containing meat and bone meal throughout their receipt, processing, and distribution; failure to label feeds which contain, or may contain, prohibited materials with the required cautionary statement "Do Not Feed to Cattle or Other Ruminants;" the unacceptable practice of flushing the mixer with cracked corn that is fed to wild game including deer, a ruminant animal; and, failure to provide measures to avoid commingling and cross-contamination of feeds containing prohibited materials with feeds containing no prohibited materials.
Mr. Gerald Bookey, Owner and Chief Executive Officer, National Foods Corporation, Shoreline, WA, received a warning letter for significant deviations from the Current Good Manufacturing Practice Regulations (GMP's). Violations included failure to prepare and maintain a receipt record for each lot of drug received; failure to maintain a daily inventory record for each drug used, failure to perform a periodic assay of medicated feeds for drug components; failure to have adequate clean-out procedures for all equipment in the manufacture and distribution of medicated feeds; failure to have a Master Record File; and, failure to retain the original production record for not less than one year.
Mr. Glenn D. Baird, President, Classic Care Products, Inc., Chattanooga, TN, received a warning letter for GMP deviations including no component testing, no master production records, incomplete batch production records, failure to conduct stability studies on finished products, no label controls, no cleaning and maintenance records for manufacturing equipment, and failure to follow Standard Operating Procedures. In addition, veterinary drug products manufactured by the firm were misbranded under Section 502(o) of the Federal Food, Drug, and Cosmetic Act, since the firm was not registered, and the veterinary products had not been listed.
Mr. Everett B. Hughes, President and CEO, Veterinary Laboratories, Inc., Lenexa, KS, received a warning letter as a result of GMP deviations including failure to establish and/or follow adequate procedures to control microbiological contamination in products purporting to be sterile; failure to perform adequate investigations on lots of aseptically filled products that were out of established sterility specifications during initial testing; failure to establish adequate procedures detailing out-of-specification investigations with reference to laboratory procedures; and, failure to have adequate complaint procedures established in that instructions concerning FDA post-marketing adverse drug experiences do not describe what needs to be reported or establish timeframes for reporting.
Mr. Robert D. DeGregorio, President, Land O'Lakes Farmland Feed, LLC, Arden Hills, MN, received a warning letter for violations in the feed mill operation located in Dodge City, KS. Deviations included failure to maintain equipment in such a manner as to prevent cross-contamination of medicated feeds; failure to have an adequate clean-out procedure to prevent unsafe contamination; failure to perform the required testing of medicated feeds containing Category II medicated articles; failure to insure that appropriate and accurate labeling is used; and, failure of the Master Files to contain mixing times for medicated feeds.