Fewer inspections from the FDA & EU

The US FDA and the EU just announced that they intend to recognize each other’s manufacturing inspections. This will likely result in fewer and duplicative inspections but may result in more stringent audits. If you have any questions about how this impacts you,...
Responding to an FDA Inspection

Responding to an FDA Inspection

Introduction The recent spate of FDA activity has resulted in the need for pharmacies to understand how to adequately respond to the FDA and the public shaming (or more) that may ensue if companies do not meet FDA expectations. Case Presentation: It is routine for the...