Template

FDA Inspection: Preparedness Checklist

1,000+

This FDA Inspection Preparation Checklist can be used to track the preparedness of a site or facility for an upcoming FDA inspection. Managers can use this as an aid to prepare the personnel, site, and documentation for an FDA inspection.

With Mitti you can

Digitize any process, procedure or policy

Eliminate mistakes made by paper-based processes

Create and share professional reports instantly

Confirm accountability and compliance with a digital log

With Mitti you can

Digitize any process, procedure or policy

Eliminate mistakes made by paper-based processes

Create and share professional reports instantly

Confirm accountability and compliance with a digital log

About author

Mitti

Mitti (by SafetyCulture) is the operations system for every site, shift and standard. Trusted by 80,000 organizations in 190 countries, Mitti publishes free checklists, SOP templates, audit checklists and toolbox talk topics that turn paper processes into a digital audit trail. Download one, put it to work on your next inspection or shift, and see why teams keep coming back for more.

Template

FDA Inspection Preparedness Checklist

This FDA inspection preparedness checklist helps clinical research sites and healthcare facilities get inspection ready. It guides teams through administrative notifications, workspace setup, and staff scheduling, and ensures equipment temperature logs, maintenance, and calibration records are current. The checklist details required regulatory documentation such as protocols, IRB or ethics approvals, informed consent forms, Form FDA 1572, CVs and licenses, training records, monitoring reports, and safety communications. Clinical sections cover source documents, CRFs, consent, visit windows, AE and EAE reporting, protocol deviations, and lab and diagnostic reports. Pharmacy and laboratory sections include accountability logs, chain of custody, temperature monitoring, and calibration records to align with GCP and FDA requirements.

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Retail Food Reopening Food Safety Checklist

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Retail Food Reopening Food Safety Checklist

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