FDA Inspection

Prepare for an FDA inspection with the FDA audit as a checklist.

Go paperless, conduct inspections easily and solve issues quicker with your teammates.

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FDA Inspection

Utilize this FDA Inspection Preparation Checklist to keep track of the preparedness of a site or facility for an upcoming FDA inspection.

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What does an FDA inspection cover?

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.

4 Examples of FDA inspection

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:

  • 1. Routine inspection
    A standard inspection is every two years for domestic facilities and about every 9 years for foreign facilities. Immediate corrective action as soon as violations are detected is assessed positively.

  • 2. Pre-approval inspection
    this is an inspection that is applied before a new product is marketed.

  • 3. Inspection based on a specific problem
    is used to investigate a problem that has been notified to the FDA.4. Follow-up of compliance - is the second inspection of violations that have already occurred.

Lumiform: your powerful app for preparing for an FDA audit

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.

Digitize checklists and internal processes with Lumiform:

  • The flexible checklist builder from Lumiform helps you to convert any individual paper list into a digital checklist without much effort.

  • In addition, we offer more than 9,000 ready-made templates to help companies get started digitally in no time.

  • Using the super intuitive mobile App, you and your teammates conduct check in the field with ease and in no time.

  • All results, images and comments are automatically bundled in a digital report.

  • Comprehensive analyses help you to identify inefficient areas in your company more quickly and thus to continuously improve your auditing and inspection processes.