Prepare for an FDA inspection with the FDA audit as a checklist.
The FDA (US Food and Drug Administration) is used to inspect facilities to determine whether regulations and laws for the manufacture, labelling and handling of products that are commercially distributed from Germany in the USA are being observed.
Companies that manufacture high-risk drugs and devices are inspected by the FDA as a matter of priority, as are newly registered facilities and those that have committed violations in the past. Here are four examples of FDA inspections you should know as a manufacturer:
With the mobile app from Lumiform you can easily perform any kind of quality and safety inspection via tablet or smartphone - online or offline. With the desktop software you can create inspection lists and evaluate the data collected in the field. This significantly reduces the risk of quality loss, occupational accidents, documentation errors and damage to reputation.