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This article was originally published in The Tan Sheet

Executive Summary

TRINITY TECHNOLOGIES HALTING DRUG PRODUCTION AND DISTRIBUTION to correct "deficiencies in its manufacturing practice that have been identified by the Food and Drug Administration," the Roseville, Mich.-based generic drugs firm said. In an Aug. 6 statement, Trinity Technologies reported that "approximately half" of its 60 employees have been laid off indefinitely. The private company manufactures approximately 13 generic, primarily prescription drugs, under its own and other labels. About four weeks prior to the announcement of its shutdown, Trinity was notified by FDA that the company was being denied a certificate of free sale. The company said it had requested the certificate for an export order due, but was denied by FDA because of noncompliance with current good manufacturing practices (cGMPs), the company said. Trinity subsequently requested a meeting with FDAers from the agency's Detroit district office. Following the Aug. 5 meeting, Trinity decided to cease production in its 30,000 square-foot plant to correct deficiencies, chiefly related to process validation, the firm said. Trinity has conducted two drug recalls in 1993, one attributed to short fill and one because the expiration date was not supported by stability data. The firm recalled 600 bottles of 1,000 tablets of phenazopyridine on May 28, for short fill that were distributed under the Rugby, Qualitest and Trinity Technologies labels. In December 1992, 1,000 bottles of 100 tablets each of Prop-A-Hist antihistamine-decongestant caplets distributed by Bolan Pharmaceutical were recalled by Trinity because of an incorrect expiration date (see Enforcement Report below.) In the fall of 1991, the firm recalled 1,464 1,000-tablet and 601 100-tablet bottles of colchicine, a gout treatment. The reason cited was failure to meet dissolution specification. All three recalls were categorized as Class III. Trinity Technologies was founded in 1984 by Walter and Matthew Szczesiul. Matthew Szczesiul is president of the firm, which manufactures primarily solid dosage forms. In the first half of 1993, Trinity had sales of about $ 4.7 mil.

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