Definition
FDA Inspection is an official examination of facilities involved in drug development and manufacturing to verify compliance with FDA regulations. Inspections cover manufacturing sites, clinical trial sites, laboratories, and sponsor operations.
How FDA Inspections Work
FDA investigators visit sites to review records, observe operations, and verify compliance. Inspections can be pre-announced or unannounced depending on type and circumstances.
Inspection Types
| Type | Purpose | Timing |
|---|---|---|
| Pre-Approval (PAI) | Verify manufacturing capability | Before NDA/ANDA approval |
| Surveillance | Routine compliance monitoring | Periodic |
| For-Cause | Investigate specific concerns | As needed |
| Bioresearch Monitoring | Verify clinical trial integrity | During/after trials |
Inspection Outcomes
| Classification | Meaning | Consequence |
|---|---|---|
| NAI | No Action Indicated | Acceptable compliance |
| VAI | Voluntary Action Indicated | Minor issues, voluntary correction |
| OAI | Official Action Indicated | Significant violations, enforcement |
Common Inspection Observations
- Documentation Failures: Incomplete batch records
- Equipment Issues: Validation or maintenance gaps
- Laboratory Problems: Out-of-spec investigations
- Personnel Training: Inadequate training documentation
- Contamination Control: Environmental monitoring gaps
Why BD Teams Track FDA Inspections
For business development professionals, inspection history affects risk:
- Deal Implication: OAI findings can delay approvals or trigger Warning Letters
- Due Diligence Focus: Review inspection history and 483 responses
- Opportunity Signal: Facilities with clean records command premium valuations