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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 Health Products describes a proposed agreement with federal investigators as a key to restarting its U.S. OTC business, but the firm's debt load makes it more likely the business will be sold

Leiner Proposes $10 Million Restitution To Enhance Its Value

Leiner Health Products describes a proposed agreement with federal investigators as a key to restarting its U.S. OTC business, but the firm's debt load makes it more likely the business will be sold

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