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Home » KV Fraud Case Could Change Drugmakers’ Disclosures on Form 483s
KV Fraud Case Could Change Drugmakers’ Disclosures on Form 483s
June 8, 2012
A class action lawsuit that presented FDA Form 483 inspection reports to allege 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.