What to Expect During an FDA Inspection in 2025: Prep Guide for Manufacturers
PUBLISHED ON:
October 03, 2025
With the FDA expanding enforcement under FSMA, inspections in 2025 are more data-driven, unannounced, and focused on preventive controls. Whether you're a new facility or a seasoned operation, knowing what to expect and how to prepare is essential.
Key trends in 2025 FDA inspections
1. Focus on Preventive Controls
Inspectors will prioritize your written food safety plan, including hazard analysis, Critical Control Points (CCPs), and preventive controls.
2. Review of Records
Expect requests for logs, traceability data, and supplier verification documentation — especially for products on the Food Traceability List (FTL).
Digital records are preferred, but organized paper records are still acceptable if complete and immediately retrievable.
3. Cross-Contact and Allergen Controls
Inspectors will review how facilities manage all nine major allergens including separation, sanitation, and labeling controls.
4. Environmental Monitoring Programs (EMPs)
For Ready-to-Eat (RTE) food operations, your pathogen monitoring plan must be risk-based and corrective actions documented.
5. Food Safety Culture Assessment
Inspectors may evaluate how staff are trained, supported, and held accountable for food safety responsibilities.
What Inspectors Look For
How to Prepare
Tools for Readiness
Resources
Final Thoughts
FDA inspections in 2025 are more structured and proactive than ever before. Preparation is the key to avoiding costly operational disruptions and regulatory action. Train your team, tighten your documentation, and review your program routinely to stay inspection-ready.
Key trends in 2025 FDA inspections
1. Focus on Preventive Controls
Inspectors will prioritize your written food safety plan, including hazard analysis, Critical Control Points (CCPs), and preventive controls.
2. Review of Records
Expect requests for logs, traceability data, and supplier verification documentation — especially for products on the Food Traceability List (FTL).
Digital records are preferred, but organized paper records are still acceptable if complete and immediately retrievable.
3. Cross-Contact and Allergen Controls
Inspectors will review how facilities manage all nine major allergens including separation, sanitation, and labeling controls.
4. Environmental Monitoring Programs (EMPs)
For Ready-to-Eat (RTE) food operations, your pathogen monitoring plan must be risk-based and corrective actions documented.
5. Food Safety Culture Assessment
Inspectors may evaluate how staff are trained, supported, and held accountable for food safety responsibilities.
What Inspectors Look For
- Written food safety + recall plans
- Validation records and monitoring logs
- Sanitation standard operating procedures
- Supplier approval and verification records
- Speed and accuracy of record retrieval
How to Prepare
- Conduct internal audits based on FDA expectations
- Ensure all records are up-to-date and accessible
- Train staff to confidently explain their role in the food safety plan
- Identify and correct issues before inspections occur
Tools for Readiness
Resources
Final Thoughts
FDA inspections in 2025 are more structured and proactive than ever before. Preparation is the key to avoiding costly operational disruptions and regulatory action. Train your team, tighten your documentation, and review your program routinely to stay inspection-ready.
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