The U.S. Food and Drug Administration (FDA) announced that it is piloting one-day inspectional assessments. These assessments will be shorter, more focused, and will complement existing standard FDA inspections.
Shorter Inspections, More Coverage
Launched in April 2026, the pilot is part of a broader initiative to make the agency’s inspectional resources more targeted and efficient. The new assessments will allow for broader coverage, enabling the agency to assess more facilities without compromising regulatory rigor.
The pilot is being conducted across multiple FDA inspectorates, including human and animal foods, biologics, medical products, and clinical research programs. Facilities are selected using risk-based criteria such as:
- Product type
- Prior inspection outcomes
- Operational characteristics
As of late April 2026, the FDA has completed approximately 46 one-day assessments.
The agency made clear that one-day inspectional assessments are not intended to replace standard FDA inspections. Instead, they are meant to provide an additional tool to the agency’s enforcement approach. The ‘one-day’ framework is also flexible – investigators retain authority to expand the scope or duration of an assessment if warranted.
The pilot will continue through fiscal year 2026. The FDA is currently developing evaluation metrics to assess effectiveness, including inspection duration, escalation rates, and the utility of findings in informing risk-based decision-making.
What Facility Owners and Operators Should Do
Facility owners and operators should remain ready for an inspection at any time. You should also review your facility’s prior inspection history. While you cannot predict when the FDA may show up, your prior inspection record is a significant factor in site selection. If you are selected for a one-day inspection, treat it like a full inspection. Investigators have full authority to stay longer or extend the scope if they find reason to do so.
Contact Diaz Trade Law for Compliance and Inspection Assistance
Diaz Trade Law assists in ensuring our clients have adequate compliance systems in place to comply with FDA regulations and successfully navigate FDA inspections.
Our team works with facility owners and operators to assess risk, strengthen internal controls, develop or revise compliance programs, and more.
If the FDA has already notified you of an inspection, we can help you prepare and navigate the process. Contact us today for assistance: 305-456-3830, info@diaztradelaw.com
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