View Cart  

Court: 483 Nondisclosure Can Be Basis for Class Action Lawsuit

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.

To View This Article:


Subscribe To Devices & Diagnostics Letter

Buy This Article Now

Add this article to your cart for $25.00