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. The pilot has ...
In a bid to better deploy its boots-on-the-ground resources, the FDA is pulling back the curtain on a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to ...
Updated FDA Manual Offers Inside Look at Inspection Protocols The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations ...
On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, Inspection of Medical Device Manufacturers (CP 7382.850), to explain how the ...
The primary market opportunities lie in equipping professionals with practical skills for preparing, managing, and responding to FDA inspections. This training addresses common challenges and ...
Looking to clarify its expectations on manufacturer responses following inspections, the FDA earlier this year unveiled, for ...
As part of a pilot program that launched in April, the agency is conducting shorter, focused screening assessments to ...
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