1. FSMA Enforcement: Focus on Inspections
ABA Food & Supplements Workshop
Maile Gradison Hermida
Hogan Lovells US LLP
June 9, 2015

2. FSMA Inspection Impacts for Industry
Phased Implementation
Systems-Based Inspections
Escalation and Appeals

3. Applying the Goldilocks Principle
If inspections are too lax, companies will not be driven to improve their programs
If inspections are too regulatory in nature (focusing on the trees instead of the forest), FDA will not incentivize companies to develop a prevention-focused food safety culture
If FDA takes a systems-based approach and phases in implementation, inspections will be just right!

4. Phased Implementation
FDA will educate before and while it regulates
Inspections and enforcement on Day 1 will look very different than in 2, 5, and 10 years
With time, FDA’s expectations will increase
See, e.g., seafood HACCP
Some companies may consider this when planning for implementation
Should programs be “good enough” on Day 1, or do they need to be at 100%?

5. Systems-Based Inspections
What does a systems-based inspection look like?
A big picture assessment, looking at
Whether the facility’s relevant food safety systems are working
The impact on food safety and public health
It means taking a step back and looking at the forest (total systems), not just the trees (non-conformities)
Approach is driven by questions and analysis

6. Systems-Based Inspections
What would inspections look like if a systems based approach is used?
Seek to understand the company’s food safety programs (e.g., sanitation, allergen control, environmental monitoring)
Ask questions to understand those programs and what the company is doing to implement them
Look to see if the company is properly implementing the programs
If there are non-conformances, consider their scope and significance
Are they systemic or isolated?
What is the food safety risk and public health impact?

7. Systems-Based Inspections
What if FDA Doesn’t Take a Systems-Based Approach?
Inspections will be inefficient and ineffective
Agency resources will be focused on technical deviations, rather than protecting the public health
Food safety could take a back seat to regulatory compliance
Companies will not be incentivized to develop a strong food safety culture
Food safety programs will be reactive, rather than proactive
FDA will only have a snapshot view of a facility

8. Escalations and Appeals
Recent trade association comments encourage FDA to develop a formal process for appealing inspection findings
Will help ensure consistent decision-making, which is particularly important given the range of experience within FDA’s inspection cadre and large number of state inspectors
Allows FDA to helps monitor inspector understanding and application of agency policy, as well as track-and-trend enforcement
Reinforces training for systems-based inspections

9. Conclusion Considerable changes to inspections are coming under FSMA
FDA’s approach to FSMA inspections will determine whether the law is a success
A systems-based approach is essential
Industry should develop a mechanism to share inspection insights as FSMA implementation progresses

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