100 Things FDA Investigators Look for During Inspections

FDA inspections aren't just regulatory checkpoints. They're detailed evaluations of your quality systems, documentation, and risk posture. Whether it's a routine inspection, a for-cause audit, or a pre-approval inspection, here are 100 elements that FDA investigators commonly review.

1 to 20: Data Integrity and Documentation (21 CFR Part 11 and ALCOA+)

1. Adherence to ALCOA+ principles
2. Accurate and contemporaneous data entries
3. Secure and validated electronic systems
4. Enabled and traceable audit trails
5. Protection against unauthorized data changes
6. Version control of forms and templates
7. Retention of raw data
8. Reconciliation of paper and digital records
9. Tampering indicators or suspicious entries
10. Backdating or post-dated logs
11. Signature authenticity
12. Unique user credentials and password policies
13. Documentation of data changes
14. Use of time-stamped entries
15. Traceability of all critical data points
16. Access logs and user permissions
17. Verification of e-signatures
18. System validation protocols
19. Gaps in chronological logs
20. Duplicated or missing records

21 to 40: SOPs, Policies, and Record Management

1. Up-to-date SOPs aligned with operations
2. Obsolete SOPs removed from use
3. Approval workflows for SOP changes
4. Training on new or revised SOPs
5. Readily accessible controlled documents
6. SOPs covering all critical operations
7. Logbooks maintained and up to date
8. Indexing and archival practices
9. Reconciliation of batch records and SOPs
10. Chain of custody logs
11. Storage conditions for archived documents
12. Document lifecycle management
13. Labeling of drafts and final versions
14. Change log histories
15. Redline tracking during SOP updates
16. Procedures for document destruction
17. Emergency use document protocols
18. Use of master templates
19. Defined retention periods
20. Controlled document distribution logs

41 to 60: Training and Staff Qualification

1. Role-based training programs
2. GCP/GMP/GLP training records
3. Qualification of new hires
4. Refresher training schedules
5. Near-real-time training status dashboards
6. Effectiveness evaluations post-training
7. CAPA-based retraining records
8. Training on new equipment or procedures
9. On-the-job competency assessments
10. Documentation of training exemptions
11. SOP acknowledgment logs
12. Cross-training records
13. Documentation of trainers' qualifications
14. Annual training calendar
15. Role-specific learning paths
16. Language and comprehension checks
17. Training deviations
18. Tracking of expired qualifications
19. Audit readiness training
20. Emergency SOP training

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61 to 80: Equipment, Calibration, and Facility Maintenance

1. Equipment qualification (IQ/OQ/PQ)
2. Preventive maintenance logs
3. Calibration certificates
4. Use of calibrated reference standards
5. Validation of cleaning procedures
6. Logbooks for usage and downtime
7. Environmental control records (temp/humidity)
8. Equipment ID and status tagging
9. Use of validated software and instruments
10. Autoclave performance verification
11. Cleanroom pressure differentials
12. Filter integrity testing
13. Refrigeration logs
14. Backup power systems
15. Changeover procedures between batches
16. Material flow separation
17. Routine inspections of facility utilities
18. Alarm system tests and logs
19. Safety and sanitation checks
20. Corrective actions for equipment failures

81 to 100: Clinical Trial and Product Quality Oversight

1. Protocol compliance in clinical trials
2. IRB/IEC documentation
3. Informed consent recordkeeping
4. Drug accountability logs
5. Blinding/unblinding documentation
6. Subject screening and enrollment logs
7. Adverse event documentation
8. Serious Adverse Event (SAE) reporting timelines
9. Subject withdrawal and follow-up records
10. Visit window deviations
11. Source data verification
12. Investigator site qualification
13. Subject inclusion/exclusion compliance
14. Randomization code security
15. Delegation of authority logs
16. Archiving clinical trial master files.
17. Inspection readiness plans
18. Monitoring visit reports
19. Sponsor audit records
20. Communication logs between the sponsor, CRO, and site

Why It Matters

Each of these 100 items represents a potential risk point or quality opportunity. Missed documentation, untrained staff, or incomplete CAPAs can lead to Form 483s, warning letters, or clinical holds.

How Atlas Helps

With Atlas, pharma and medical device quality teams can:

• Access near-real-time inspection trends across 30,000+ Form 483s and EIRs and 11,828 warning letters
• Monitor FDA investigator behavior and citation patterns through 6,000+ investigator reports
• Benchmark CAPAs, SOPs, and training against what investigators are actually citing
• Use the AI copilot to surface gaps and suggest improvements in any language
• Stay organized with custom analytics and alerts tailored to your suppliers, peers, and regulatory focus areas