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
Focus on preventive controls
Inspectors will prioritize your written food safety plan, including hazard analysis, critical control points (CCPs), and preventive controls.
Review of records
Expect requests for logs, traceability data, and supplier verification especially for products on the Food Traceability List (FTL). While digital records are increasingly common, the FDA still accepts well-maintained paper systems, provided they are complete and retrievable.
Cross-contact and allergen controls
Facilities will be reviewed on how they manage all nine major allergens (Milk, Eggs, Fish, Shellfish, Tree nuts, Peanuts, Wheat, Soybeans, and Sesame). Clear labeling, effective separation, and strong sanitation practices are essential to compliance.
Environmental monitoring programs (EMPs)
For ready-to-eat facilities, the presence and execution of a pathogen EMP is under greater scrutiny. Inspectors will want to see evidence that your sampling plan is risk-based and your corrective actions are well-documented.
Food safety culture assessment
Inspectors may ask how you train, reward, and empower staff to uphold food safety. Expect questions about communication, accountability, and management commitment.

What inspectors look for

• Your written food safety and recall plans
• Validation records and monitoring logs
• Sanitation SOPs and allergen controls
• Supplier documentation
• How quickly you can provide requested documents

How to prepare

• Conduct internal audits: Use FDA guidance and past inspectional observations as benchmarks to test your system.
• Ensure records are accessible and complete: Paper or digital, you must retrieve them quickly and in full.
• Train staff to answer inspection questions: Employees should understand their roles within the food safety system.
• Fix known issues before the FDA arrives: Conduct root cause analysis and document corrective actions for any deviations.

Tools for readiness
Go HACCP helps manufacturers get inspection-ready by:

• Reviewing your food safety plan and documentation for gaps
• Providing templates and checklists modeled on FDA expectations
• Using IQOps to centralize and automate recordkeeping
• Offering internal audit support and audit coaching

Resources

• FDA Inspection Overview
• FSMA Compliance Guide

Final Thoughts
FDA inspections in 2025 are more structured and risk-based than ever before. Being proactive not reactive can save your business from warning letters, recalls, or shutdowns. Start with a strong plan, train your team, and use the right tools to stay ahead.