FDA Launches One-Day Inspections
- Date
- May 6, 2026
- Category
US Regulations
- Description
The U.S. Food and Drug Administration (FDA) has introduced a new “one-day inspectional assessment” program aimed at strengthening oversight across FDA-regulated industries while improving inspection efficiency.
The new approach allows FDA investigators to conduct shorter, targeted inspections focused on recurring compliance themes, facility-specific risk scores, and discrepancies between registered and actual operations. FDA stated that the assessments are designed to complement – not replace – traditional inspections. However, if investigators identify significant concerns during the visit, inspections may be expanded beyond one day. For manufacturers, the change highlights the growing importance of continuous inspection readiness, strong documentation practices, and risk-based quality management.
The One Day Inspections are aligning with previous FDA Actions of Modernization such as the new QMSR with its ISO 13485 incorporation or Remote Regulatory Assessments. It becomes more important for manufacturers to follow a risk-based approach on FDA inspections and maintain FDA readiness all time, specifically for critical devices. For this, NSF, can support you with:
- Regulatory Consulting
- Inspection Readiness Training and Mock FDA inspections
- Quality System assessments
- CAPA and Compliance reviews
Link: FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight | FDA