FiercePharma

Mallinckrodt faces regulatory delay as COVID-19 restrictions continue to upend FDA's inspection schedule

As COVID-19 continues to run rampant, the FDA has struggled to keep its manufacturing inspection schedule on track. This week, Mallinckrodt became the latest regulatory victim. Mallinckrodt will have ...
FiercePharma

FDA's inspection woes to grow if agency doesn't address COVID-19 backlog: GAO

The U.S. Government Accountability Office (GAO) has concerns about the FDA's widening inspection backlog. COVID-19 certainly amplified the problem, but the issues had been mounting long before last ...
Seeking Alpha

Hexagon halves quality inspection cycles and enables flexible manufacturing with the PRESTO robotic inspection cell

HANNOVER, Germany, April 18, 2023 /PRNewswire/ -- Hexagon's Manufacturing Intelligence division has launched its new automated robotic inspection cell PRESTO, enabling manufacturers to reduce quality ...
JD Supra

FDA finalizes RRA manufacturing inspection guidance as US focuses on supply chain security

The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records ...
Contract Pharma

MedPharm Completes FDA Inspection for Commercial Manufacture of Drug Products

MedPharm’s topical drug product manufacturing facility in Durham has successfully completed an FDA inspection for commercial ...
Health Affairs

FDA Global Drug Inspections: Surveillance Of Manufacturing Establishments Remains Well Below Pre-COVID-19 Levels

Emily Cuddy, Duke University, Durham, North Carolina. Yun Peng Lu, University of Maryland, College Park, Maryland. David B. Ridley ([email protected]), Duke University. During the initial phase of the ...