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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities - March/April 2002

FDA Veterinarian Newsletter 2002 Volume XVII, No II

The following firms/individuals received warning letters for offering animals for slaughter that contained illegal drug residues:

  • Dr. Rhodnick B. Lowe, Rowan Animal Clinic, Salisbury, NC
  • James A. Van Haitsma, Van Haitsma Dairy Farm, Falmouth, MI
  • Alger H. Vos, President, Vos Dairy, Inc., Arlington, WA
  • Bennett J. Palmer, Jr., Co-Owner, Palmer Farms, Holland, NY
  • J. Randall Mayes, Pulaski, TN
  • Dr. Wyatt C. Galbraith, Animal Clinic, Pulaski, TN
  • David W. Goodrich, Owner, Goodrich Farms, LLP, Deer Park, WI

These violations involved illegal residues of phenylbutazone in a dairy cow, gentamicin in a dairy cow, tylosin in a dairy cow, penicillin in dairy cows, gentamicin in a dairy cow, and penicillin in a dairy cow.

A warning letter was issued to Robert T. Shinn, Owner, The Feed Bucket, Mooresville, NC, 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).

Violations included failure to label products with the required cautionary statement "Do Not Feed to Cattle or Other Ruminants." Also, customer records were not sufficient to track the distribution of products that contain, or may contain, prohibited material.

William Neuberg, Owner, Shamrock Technologies, Inc., Dayton, NJ, received a warning letter for significant deviations from the Current Good Manufacturing Practices Regulations (cGMPs), 21 CFR 210, 211, related to his firm's manufacture of veterinary drug products. Significant observations included: no assurance that the veterinary drug products Androhep Plus and Androhep Lite are not contaminated with various industrial products, such as waxes, polyterafluoroethylene and polyethylene mixes made in the same blender. The firm does not have validated cleaning procedures and does not perform any testing on the veterinary drug products for the presence of industrial products. In addition, the manufacturing process for the above products is not validated, i.e., there is no documentation to support the manufacturing parameters, the order and amount of components, and blending time used to manufacture the finished veterinary drug products. The firm also fails to perform any testing or receive a Certificate of Analysis (COA) to verify the identity of the active raw materials, Gentamicin Sulfate and Neomycin Sulfate. The firm fails to store the finished products Androhep Plus and Androhep Lite according to the temperature conditions stated on the product label.

Shamrock Technologies has responded that they will not produce any drug products in its Newark plant. Based on this statement, FDA has cancelled their drug registration.

Fred Rogers Adams, Jr., President, Cal-Maine Foods, Inc., Jackson, MS, received a warning letter for significant deviations from Current Good Manufacturing Practices regulations for medicated feeds, 21 CFR 225. Violations included failure to maintain correct documentation of actual drug usage during production, failure to conduct required potency assays on at least three representative samples of each feed at periodic intervals during the calendar year, failure to manufacture medicated feeds in accordance with the master file formula, failure to maintain a daily inventory of each drug used, and, failure to maintain complete master record files and production records.