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FDA pre-approval inspection checklist

FDA pre-approval inspection checklist

Detailed FDA pre-approval inspection checklist with sign in and sign off

Use this template
or download pdf
FDA pre-approval inspection checklist

Detailed FDA pre-approval inspection checklist with sign in and sign off

Use this template
or download pdf

About the FDA pre-approval inspection checklist

Transform the daunting task of FDA pre-approval into a streamlined, stress-free experience with a comprehensive FDA pre-approval inspection checklist template. This essential guide covers critical tasks such as reviewing regulatory documents, ensuring equipment calibration, and verifying staff training. It also includes tips on organizing documentation and conducting mock inspections. With this template, you can confidently navigate the inspection process and set your team up for success.

Prepping for approvals with a digital FDA pre-approval inspection checklist 

  You have the power to achieve seamless FDA pre-approval inspections with a structured approach via a template process that ensures comprehensive preparation. By systematically covering all critical aspects, from document reviews to equipment checks and training verification, you can enhance compliance and accountability.    Additionally, this method powered by the FDA pre-approval inspection checklist template helps identify and address potential issues early, preventing problems before they arise. Consistency is maintained, providing a reliable format for inspection preparation that boosts overall team efficiency. Additionally, thorough documentation of all inspection-related activities serves as a valuable tool for performance reviews and regulatory audits, ensuring your organization is always ready for FDA scrutiny.  

What a proper FDA pre-approval inspection checklist template contains

A great FDA pre-approval inspection checklist template includes several key elements designed to cover all aspects of inspection preparation:  
  • Document reviews: Locate, compile, organize, and review regulatory documents for accuracy and completeness.
  • Equipment checks: Ensure equipment maintenance and calibration records are available and current.
  • Training verification: Verify that all staff training is up-to-date and documented.
  • Staff schedules: Review staff schedules to ensure availability during the inspection.
  • 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 feature covers comprehensive and organized documentation, enhancing accountability and operational efficiency.   Ensure seamless FDA pre-approval inspections with a structured approach that enhances compliance and accountability.    Covering all critical aspects, from document reviews to equipment checks, this method identifies potential issues early and maintains consistency. Boost your team's efficiency and confidence with a reliable preparation format. Plus, thorough documentation aids in performance reviews and regulatory audits, keeping your organization always inspection-ready.  

Related categories

  • Risk management and compliance templates
  • Food manufacturing templates
  • Food safety templates
Preview of the template
Page 1
Sign In
Name
Company
Date
Facility Information
Facility Name
Address
Phone
Facility Type
Regulatory Status
Personnel
Responsible Person
Qualified Person
Trained Staff
Quality Management System
Quality Manual Available
Change Control Procedures
Deviations Documented
Corrective and Preventive Actions
Facility and Equipment
Appropriate Facility Design
Suitable Equipment Calibration
Preventative Maintenance Program
Documentation and Records
SOPs Available
Documentation Controlled
Batch Records Complete
Sign Off
Inspector Name
Inspector Signature
Date

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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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