Template

FDA Inspection Preparedness Checklist

by Mamie Panda, from the Community

10+

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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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 SafetyCulture 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

Community

This community page makes available free workplace checklists and templates created by other users within the SafetyCulture community. SafetyCulture has re-published this content and where possible, has credited the original author. SafetyCulture has not verified the accuracy, reliability or suitability of any community content. You agree that your use of any of this content is in accordance with SafetyCulture’s Terms and Conditions.

Template
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FDA Inspection Preparedness Checklist

About author

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