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FDAnews Device Daily Bulletin
July 12, 2012 | Vol. 9 No. 136
Appeals Court Rules 483s Can Be Used to Prove False Statements
A class action lawsuit that used FDA Form 483 inspection reports to demonstrate that KV Pharmaceutical made false or misleading statements regarding its regulatory compliance can proceed even though inspection reports are not final agency determinations, an appeals court ruled. This decision, which reverses a 2010 lower court decision to dismiss the complaint, may have broader implications for how and when devicemakers communicate inspection findings to shareholders.
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