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UNITED STATES v. TRI-BIO LABS.

August 31, 1988

UNITED STATES of AMERICA, Plaintiff,
v.
TRI-BIO LABORATORIES, INC., and DENNIS C. WINKLER, Defendants



The opinion of the court was delivered by: MUIR

 I. Introduction.

 On May 17, 1988, the United States of America (hereinafter "United States") filed this action against Tri-Bio Laboratories (hereinafter "Tri-Bio") and Dennis C. Winkler (hereinafter "Winkler"). The complaint seeks to enjoin Tri-Bio and Winkler from manufacturing Gentaject, an injectable antibiotic drug intended for use in day-old chickens, and to require Tri-Bio and Winkler to bear the costs of inspections of Tri-Bio to ensure compliance with such an injunction. Also, on May 17, 1988, the United States filed a motion for a preliminary injunction seeking the same relief.

 On August 4, 1988, a hearing was held on the motion of the United States for a preliminary injunction. At the hearing the Defendants consented to the issuance of a preliminary injunction enjoining Tri-Bio and Winkler from manufacturing Gentaject and authorizing employees of the United States Food and Drug Administration to inspect Tri-Bio Laboratories to ensure compliance with the preliminary injunction. The hearing was therefore limited to the question of whether Tri-Bio and Winkler should bear the costs of the inspections of Tri-Bio.

 The following are the Court's findings of fact, discussion, and conclusions of law.

 1. Defendant Tri-Bio Laboratories, Inc. is a corporation incorporated under the laws of the Commonwealth of Pennsylvania and doing business at 1400 Fox Hill Road, State College, Pennsylvania.

 2. Defendant Dennis C. Winkler is the president of Tri-Bio.

 3. Winkler is active in the daily operation of the company, and is the person most responsible for the company's activities.

 4. Tri-Bio and Winkler have manufactured and distributed in interstate commerce Gentaject, a drug within the meaning of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g)(1).

 5. Tri-Bio and Winkler received gentamicin sulfate, a component used in the manufacture of Gentaject, from sources outside Pennsylvania.

 6. By complaint filed on April 29, 1983, in the United States District Court for the Middle District of Pennsylvania, Civil Action No. 83-0559, Tri-Bio requested that a declaratory judgment be entered against the United States of America and the Food and Drug Administration declaring that Gentaject was not a new animal drug within the meaning of the Food and Drug Administration Act.

 7. By Stipulation of Voluntary Dismissal dated June 30, 1984, Civil Action No. 83-0559 was dismissed.

 8. In conjunction with the dismissal of Civil Action No. 83-0559, the United States of America agreed that it would not initiate any enforcement litigation against Tri-Bio or its officers for a period of 30 days from the date of the Stipulation of Voluntary Dismissal or 30 days after any denial of a citizen's petition to be ...


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