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FDA inspection checklist

FDA inspection checklist

Use this FDA inspection template to keep track of the preparedness of a site or facility for an upcoming FDA inspection.

Use this template
or download pdf
FDA inspection checklist

Use this FDA inspection template to keep track of the preparedness of a site or facility for an upcoming FDA inspection.

Use this template
or download pdf

About the FDA inspection checklist

Ever wondered what it's like when the FDA arrives unexpectedly or the consequences of non-compliance? Your reputation and credibility are crucial in FDA-regulated industries. Ensure peace of mind with a standard FDA inspection checklist template, guaranteeing your processes are safe. No more scrambling for documents or hoping everything is in order. Transform inspection jitters into confidence with our free checklist. Consider it your step-by-step guide to a smooth, stress-free visit.

Mastering FDA inspections with an effective ultimate FDA inspection checklist template 

  Save your enterprise with proactive compliance actions. The FDA inspection checklist template is your ultimate tool for mastering FDA inspections. This dynamic template ensures your team covers every critical aspect, from administrative tasks to equipment checks and regulatory document reviews.    Key benefits include heightened compliance, as it guarantees all essential steps are systematically followed, boosting accountability and spotting potential issues early. The template drives consistency, offering a reliable format that supercharges team efficiency. By documenting all inspection-related activities, it becomes an invaluable asset for performance reviews and regulatory audits.   Transform your inspection prep with this powerful, structured approach and stay ahead of the game.  

Standard elements of a standard FDA inspection checklist template

The FDA inspection checklist template includes several key elements designed to cover all aspects of inspection preparation:  
  • Administrative tasks: Notify all relevant parties of the impending 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.
  • 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 component ensures comprehensive and organized documentation, enhancing accountability and operational efficiency.  

Optimize Your FDA inspection prep with Lumiform’s checklist template

Ready to streamline your FDA inspection preparations? Download Lumiform’s free FDA inspection checklist template today and ensure thorough documentation of all activities. This comprehensive template covers every critical aspect, from administrative tasks to equipment checks. Sign up now to access this invaluable tool and other valuable templates, boosting your compliance and inspection readiness.

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Preview of the template
Administrative
Notify all parties of impending inspection
IRB/EC
Sponsor
Principal Investigator
Sub-Investigator(s)
Study Coordinator(s)
Pharmacy
Medical Records
Laboratory(ies)
Administration
Reception Area Staff
Legal Counsel
Review FDA Inspection Preparation SOP
FDA Inspection Preparation SOP
FDA Inspection Preparation SOP Work space
Copier
Table
Telephone
Review staff and clinic schedules
Reschedule non-essential visits/meetings if possible
Review staff schedules (vacations, appointments, miscellaneous time off, etc.) to ensure staff availability
Clinic Equipment
Ensure equipment maintenance and calibration records are available and current (e.g. electronic scales, electronic blood pressure cuff, etc.) (if applicable)
Ensure temperature logs for applicable clinic equipment are complete and current (refrigerators, freezers, storage cabinets, etc.)
Regulatory
Locate, compile, organize, and review documents for accuracy and completeness List of Principal Investigator’s current active protocols
Locate, compile, organize, and review documents for accuracy and completeness
Signature log (list of key site personnel and corresponding signatures; current and signed) (may be combined with the delegation log)
Delegation log (list of personnel and delegated study responsibilities; current and signed)
Master Subject Log (list of all subjects including name, contact information, enrollment and completion dates)
Screening Log (names of all participants screened including enrollment date and reason for screen failure if applicable; ensure log is current and legible)
Randomization Log (if applicable)
Protocol amendments and clarification memorandums
Protocol (all versions)
Enrollment Log (if applicable)
IRB/EC approved Informed Consent Forms (all versions including screening consent forms)
IRB/EC initial protocol approval letter
IRB/EC continuing review approval letters
IRB/EC protocol amendment(s) approval letter(s)
IRB/EC approval letter(s) for revised Informed Consent Forms
Investigator’s Brochure(s) and/or Package Insert(s) (all versions)
Evidence of EAE submission to the IRB/EC/sponsor
IRB/EC approval letter(s) for subject recruitment materials (advertisements, videos, handouts to participants, etc.)
Evidence of identification and reporting of protocol violations/deviations to the IRB/EC/sponsor per IRB/EC and protocol requirements
DSMB summary report(s) and documentation of submission to the IRB/EC
Documentation of protocol registration submission, approval, activation, and deregistration (if applicable)
IND Safety Reports/Memos and evidence of submission to the IRB/EC
All sponsor correspondence
Any other correspondence pertinent to the study (e.g. protocol team)
All correspondence to and from the IRB/EC pertinent to the study
Form FDA 1572 (all versions)
Financial Disclosure Forms (Principal Investigator and Sub-Investigators listed on the Form FDA 1572
Licenses (Principal Investigator, Sub-Investigators, and other key staff members)
Good Clinical Practice/ Human Subjects Protection training documentation for individuals listed on the Form FDA 1572 and any clinical research site personnel who have more than minimal involvement with the conduct of the research
CVs (Principal Investigator, Sub-Investigators, and other key staff members; current and signed)
Documentation of additional staff training (if applicable)
Documentation of staff protocol training
Study recruitment and retention plan
Site Standard Operating Procedures
Annual CQMP Summary Review submitted to Sponsor.
Site Standard Operating Procedures Signed and dated monitoring visit log
All monitoring pre-visit letters and monitoring reports
Documentation
Source documents and medical records are available for each participant (Review for ALCOA) (Alternative: Source documents and corresponding Case Report Forms (CRFs) for each participant are present, clearly identified, and systematically organized in binders or folders for ease of retrieval during the inspection)
Ensure the following has been completed for each participant
Original signed and dated Informed Consent Forms on file for each participant
Completed Case Report Forms (CRFs) on file for each participant
All visits conducted within protocol windows
Inclusion/exclusion criteria for each participant have been met and documented
Adverse Events (AEs), and Expedited Adverse Events (EAEs) have been identified and documented appropriately
Correct volume of blood and correct tube type drawn at each visit
All EAEs have been reported to the IRB/EC
All AEs and EAEs have been reported to the sponsor per study requirements
Protocol endpoints have been identified and reported appropriately
Protocol-required tests/evaluations have been completed and documented appropriately
Ensure study product use by all participants has been documented
Concomitant/prohibited medications have been documented and reported appropriately
Protocol violations/ deviations have been identified and documented appropriately
All laboratory reports and other diagnostic test reports are on file and display correct participant identifiers
Laboratory reports have been signed by the PI or designated medical officer
Premature discontinuations of participants are documented appropriately per study requirements
All laboratory results have been graded appropriately by the PI or designated medical officer per the DAIDS AE Grading Table and protocol-requirements
Pharmacy
CV of pharmacist(s)
Licenses of pharmacy personnel
Locate, compile, organize, and review documents for accuracy and completeness
CVs of key pharmacy personnel
Form FDA 1572
Prescriber signature list
Most recent version of the protocol-specific study procedures (i.e. SSP manual)
Most recent version of the protocol for which the site has IRB/EC approval
Records of study product dispensation to appropriate staff member (if applicable)
CRPMC Drug Supply Statement (version for which site is protocol registered)
Investigational agent accountability logs
Most recent version of Investigator’s Brochure(s) or Package Insert(s)
Documentation of study drug transfers, returns, and destruction (if applicable)
Participant prescriptions
Documentation of study drug transfers, returns, and destruction (if applicable) Ordering/shipping receipts
DAIDS-approved, signed Pharmacy Establishment Plan
Required pharmacy operations SOPs as listed in the PAB Pharmacy Guidelines (July 2008)
Participant-specific profiles (if applicable)
Laboratory
Licenses of laboratory personnel (if applicable)
Locate, compile, organize, and review documents for accuracy and completeness
Laboratory certifications
CVs of key laboratory personnel
Laboratory normal ranges
Laboratory Data Management System (LDMS) records
CV of Laboratory Director
Copies of laboratory audits, action plans, and corrective action reports
Specimen logs (present and readily available for review)
Chain of Custody SOP (or similar process document)
Chain of Custody SOP (or similar process document)
Corresponding control data for assays where laboratory result AEs and EAEs were identified
Calibration and maintenance records for all laboratory equipment (if applicable)
Temperature logs for applicable equipment (refrigerators, freezers, storage cabinets, etc.)
Vertical audit of laboratory results and corresponding QC data for results of a randomly selected sample
Corrective action reports for identified temperature excursions
Completion
General comments and observations
Sign off
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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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