US FDA Looks To Resume Unannounced Inspections In India And China
Executive Summary
After lapsing due to COVID-19, an unannounced foreign inspection pilot program is on track to resume in 2022, “despite challenges and constraints of travel.”
You may also be interested in...
House User Fee Bill’s Inspections Provisions Would Add Layers Of Scrutiny Abroad
Inspection subsection would penalize high-quality sites in low-quality foreign regions with greater inspection frequency, while adding more surprise inspections and requiring greater internal FDA coordination to prevent quality issues from causing drug shortages.
House User Fee Bill’s Inspections Provisions Would Add Layers Of Scrutiny Abroad
Inspection subsection would penalize high-quality sites in low-quality foreign regions with greater inspection frequency, while adding more surprise inspections and requiring greater internal US FDA coordination to prevent quality issues from causing drug shortages.
US FDA Strengthens Inspection Capabilities With Pandemic Alternatives – And Travel Savings
Agency’s Office of Regulatory Affairs mines third-country EU inspections and remotely delivered documents while investing travel savings, redirecting field force and preparing for new post-pandemic travel challenges.