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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

SafetyCulture

Mitti (by SafetyCulture) is the operations system for every site, shift and standard. Trusted by over 80,000 organisations, Mitti brings your people, operational data and workflows into one operating picture. From the frontline to the boardroom, it gives everyone a clear understanding of what's happening, highlights what needs attention and recommends what to do next. Every inspection completed, issue raised and action taken becomes intelligence your teams can use to improve every day.

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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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FDA GMP Cosmetics Audit Checklist

This digital GMP Cosmetics Checklist has been built using the SafetyCulture app and based on the FDA's GMP Cosmetic Guidelines. Use this digital GMP checklist to assess your manufacturing compliance with FDA guidelines across aspects of building and facilities, equipment, personnel, raw materials, production, lab controls, record keeping, labelling and complaints. Use SafetyCulture to take notes and photo evidence of non-compliance. Automatically calculate your audit score based on the responses and generate a complete report without leaving your manufacturing facility. Save all your reports securely in the cloud.

by SafetyCulture

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Retail Food Reopening Food Safety Checklist

This FDA aligned checklist helps retail food establishments reopen safely after COVID 19 shutdowns or limited service. It covers facility readiness, utilities and ventilation checks, deep cleaning and disinfection, food contact surface sanitation, temperature control and calibrated thermometers, product inspection and rotation, warewashing and sanitizer verification, handwashing station setup, employee health screening and PPE or cloth face coverings, and practical social distancing controls. References to CDC, EPA, OSHA, and FDA resources support compliance and ongoing training.

by SafetyCulture

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MDSAP Audit Checklist for FDA Compliance

This FDA based MDSAP audit checklist helps medical device manufacturers assess the alignment of their quality management system with MDSAP requirements. The template guides reviewers through QMS scope and documentation, leadership and policy, planning, resources and competence, operational planning and control, product and service release, control of nonconforming outputs, performance evaluation, customer feedback and complaints, internal audits, management review, corrective and preventive actions, and continual improvement. Use it to prepare for audits and strengthen compliance.

by Cesar Paredes, from the Community

10+

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