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Leiner’s Return To U.S. OTC Market Complicated By FDA Warning, DOJ Inquiry

This article was originally published in The Tan Sheet

Executive Summary

FDA's investigation into manufacturing and quality control issues at Leiner Health Products' South Carolina facility revealed a culture of mismanagement that created a pattern of undetected production errors and overlooked discrepancies regarding product development, according to the agency

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Leiner to redistribute products

FDA's Atlanta District Office grants Leiner Healthcare Products permission to begin distributing previously manufactured OTC products if a third-party quality assessment deems the products acceptable under FDA methodology. In an Oct. 22 Securities and Exchange Commission filing, the Carson, Calif.-based firm says it will begin re-distributing a portion of its inventory in December. Leiner suspended its U.S. OTC production and distribution March 20 and initiated a voluntary recall in April after FDA found GMP discrepancies at the firm's Fort Mill, S.C., facility (1"The Tan Sheet" Sept. 24. 2007, p. 12)

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