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Home » Court: 483 Nondisclosure Can Be Basis for Class Action Lawsuit
Court: 483 Nondisclosure Can Be Basis for Class Action Lawsuit
June 8, 2012
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.