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U.S. Department of Health and Human Services

Animal & Veterinary

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LAMPLEY ORDERED TO CORRECT PAST VIOLATIONS

FDA Veterinarian Newsletter September/October 1998 Volume XIII, No V

On March 13, 1998, the Federal Court for the Eastern District of Pennsylvania found Mr. Frank Lampley from Glenmoore, Pennsylvania, to be in indirect contempt of a 1992 permanent injunction order. The original order prohibited Mr. Lampley from distributing adulterated or misbranded animal drugs in interstate commerce. The Court ruled that Mr. Lampley had continued to promote and sell unapproved new animal drugs such as "Formula S," "External Rub," "Vitamix," "Formula M," and "Mineral and Protein Mix," in spite of the 1992 injunction.

Mr. Lampley failed to appear for a follow-up court hearing scheduled for May 26, 1998, while continuing to advertise and promote his unapproved new animal drug products. On June 25, 1998, the United States District Court for the Eastern District of Pennsylvania entered an order requiring Mr. Lampley to cure his past violations by July 31, 1998, including sending a notification, drafted verbatim by the Court, to all his past customers since June 19, 1992, that his drugs contained claims that FDA found to be not approved; providing a certification to the court as to which persons he notified; and withdrawing and destroying all past advertising and promotion. The Court has ordered that Mr. Lampley submit a draft copy of this customer letter to the Court for consideration by close of business July 6, 1998. In addition, Mr. Lampley must submit evidence that he has taken all necessary measures to withdraw the advertising and promotional material that directly, or indirectly promotes, advertises, or suggests that any of his products can diagnose, cure, mitigate, treat, prevent, aid in the treatment of disease in animals, or affect the structure or function of the bodies of animals. Mr. Lampley was ordered to destroy by July 24, 1998, all existing labeling, advertising, and promotional material for such products.

The Food and Drug Administration may conduct an inspection of Mr. Lampley’s premises after July 31, 1998, to determine his compliance with the Court Order.

In the event that Mr. Lampley fails to comply with any part of the order he would be subject to a fine in the amount of $500 per day, beginning on August 3, 1998.

This case involved a joint effort by FDA’s Office of General Counsel, Office of Regulatory Affairs, Philadelphia District Office, and the Center for Veterinary Medicine.

REGULATORY ACTIVITIES

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

  • Antonio D. Carvalho, Riverdale, CA
  • James Myer, Lititz, PA
  • Andrew J. Ormonde, A.T.O. Dairy, Riverdale, CA
  • Frank Borba, Escalon, CA

These violations involved illegal residues of gentamicin in a cow; tilmicosin in a cow; sulfadimethoxine in a dairy cow; and gentamicin, penicillin, and sulfadimethoxine in a cow.

Warning letters were sent to the following firms/individuals for violations from Good Manufacturing Practices (GMPs):

  • J. Gordon Dixon, President, Animal Repellants Inc. (ARI), Orchard Hill, GA
  • Mike Reed, President and CEO, PM Ag Products, Inc., Homewood, IL

A warning letter was sent to Joe Edge, Co-Owner, Aubrey/Pilot Professional Products, Pilot Point, TX, for the sale and promotion of veterinary drugs which were adulterated and misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act.