Are Your Teams Ready? FDA Announces One-day Site Assessments

FDA One-day Site AssessmentsFDA’s recent announcement of One-Day Inspectional Assessments is an important reminder that regulatory compliance and readiness should always be actively implemented and championed from the leadership team to the manufacturing floor. As of late April 2026, the FDA has completed approximately 46 one-day assessments. Most assessments successfully confirmed compliance, resulting in No Action Indicated (NAI) outcomes. According to FDA’s data dashboard the top five citations for fiscal year 2026 so far include: issues with foreign supplier verification program documents, sanitary operations-plant maintenance, pest control, personnel cleanliness/disease control and manufacturing processing and packaging controls. If you need help in any of these areas or learning how to manage a regulatory inspection, contact RQA. Our consultants can support your team achieving proactive compliance before the inspection.

FDA Article:
FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight

FDA Dashboard:
FDA Dashboards – Inspections

Regards,
Melanie Whitman