Leiner Health Products Submits Proposed Agreement with Department of Justice to U.S. Bankruptcy Court for Approval
May 10th, 2008 | by admin |Resolves Allegations of Compliance Matters at Defunct Facility
CARSON, Calif., May 9 /PRNewswire/ — Leiner Health Products Inc.(”Leiner” or “the Company”) announced today that it has submitted aproposed agreement with the United States Department of Justice to the U.S.Bankruptcy Court in Delaware for approval. The proposed agreement wouldresolve the previously disclosed investigation concerning the production,control and distribution of certain over-the-counter (OTC) drug products atthe Company’s now defunct Fort Mill, South Carolina facility. The agreementis subject to approval and acceptance by the United States District Courtin Columbia, South Carolina.
This agreement would resolve the government’s investigation ofallegations against Leiner, which were related to a previously disclosedForm 483 report the Company received from the Food and Drug Administration(FDA) on March 16, 2007. Both the investigation and the Form 483 pertainedto activities that took place at the now closed Fort Mill facility prior tothe arrival of the current Quality Control management team.
“Leiner took immediate action to correct this situation,” said RobertK. Reynolds, CEO and President of Leiner. “In addition to the closure ofthe affected facility, we also restructured our Quality Control systems,including top to bottom personnel changes and implementation ofstrengthened compliance programs to ensure that all products conform toLeiner’s rigorous standards.”
Under the terms of the agreement, Leiner Health Products, LLC, asubsidiary of Leiner Health Products Inc., would enter a plea of guilty toone count of mail fraud and would forfeit $10 million in cash in lieu of afine. The agreement in no way implicates or affects Leiner’s ability tomanufacture and distribute vitamin and mineral products.
Mr. Reynolds continued, “We are pleased to put these issues behind us,and we are committed to providing consumers with the best valuSOURCE Leiner Health Products Inc.Copyright©2008 PR Newswire.All rights reserved
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