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FDA inspection readiness checklist

FDA inspection readiness checklist

A comprehensive checklist to prepare for an FDA inspection.

Use this template
or download pdf
FDA inspection readiness checklist

A comprehensive checklist to prepare for an FDA inspection.

Use this template
or download pdf

About the FDA inspection readiness checklist

About the template

Imagine the peace of mind knowing your team is fully prepared for an upcoming FDA inspection. An FDA inspection preparedness checklist template makes that a reality. It guides you through essential tasks such as notifying key personnel, reviewing work schedules, and ensuring all equipment and documents meet regulatory standards. With this template, you can transform the daunting inspection process into a manageable and organized routine, ensuring nothing is overlooked and your team is always inspection-ready.  

Build inspection readiness with a standard FDA inspection checklist

Effective FDA inspection readiness checklist templates empower your team to navigate inspections with efficiency and clarity.  A standard one provides a structured framework, ensuring all critical aspects – from initial notifications to equipment checks and regulatory document reviews –  are systematically addressed.     Its comprehensive structure fosters a culture of accountability by meticulously guiding your team through all necessary steps.  A great template design also promotes proactive identification and resolution of potential issues, preventing them from escalating into compliance concerns.   Furthermore, an industry-compliant checklist serves as a valuable tool for boosting efficiency.  By maintaining consistency with a reliable format, the template streamlines the inspection preparation process, saving your team valuable time and resources.  Additionally, the template encourages comprehensive documentation of all inspection-related activities.  This record serves as a crucial resource for future performance reviews and regulatory audits, fostering confidence in your team's preparedness.  

Key elements of the FDA inspection readiness checklist template

An FDA inspection readiness checklist template should cover all aspects of inspection preparation:  
  • Administrative notifications: Notify all relevant parties of the impending inspection.
  • Staff schedules: Review staff schedules to ensure availability during the inspection.
  • Equipment checks: Ensure equipment maintenance and calibration records are available and current.
  • Regulatory document reviews: Locate, compile, organize, and review documents for accuracy and completeness.
  • Workspace preparation: Ensure workspaces (e.g., copier, table, telephone) are available.
  • Bonus: Make it Yours! Customize the template with additional fields and modify sections to perfectly fit your project's specific needs.
  • Work Automation Features: Assign tasks, complete with automatic reminders, to keep your team accountable and focused on success.
  Each template component ensures comprehensive and organized documentation, enhancing accountability and operational efficiency.Don't wait for the next inspection to scramble!   

Download Lumiform's free FDA inspection readiness checklist template today.  

This easy-to-use tool empowers your team to navigate inspections with confidence. Streamline your preparation process, ensure compliance, and free up valuable time for your team.  Get started now and achieve inspection readiness with peace of mind.    
Preview of the template
Page 1
Facility Preparedness
Facility exterior and grounds are well-maintained
Facility entry and access points are controlled
Facility layout and flow are organized
Facility lighting, ventilation, and temperature are suitable
Documentation and Records
Standard operating procedures (SOPs) are up-to-date
Training records are complete and organized
Deviation and investigation reports are thorough
Batch records are accurate and readily available
Quality Systems
Quality control testing is performed as scheduled
Product quality reviews are conducted regularly
Complaints and recalls are handled efficiently
Corrective and preventive actions (CAPAs) are effective
Personnel and Training
All personnel are properly trained and qualified
Personnel hygiene and attire are appropriate
Personnel access and responsibilities are clearly defined
Continuous training program is in place
Materials and Inventory
Raw materials are tested and approved prior to use
Inventory control and material storage are adequate
Quarantine and disposition of non-conforming materials
Supplier qualification and evaluation program is in place
Equipment and Utilities
Equipment is properly maintained and calibrated
Utilities (water, air, power) are suitable and monitored
Cleaning and sanitization procedures are effective
Computerized systems are validated and secure

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This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.
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