Lupin’s Corporate Quality Oversight Questioned In FDA Warning Letter
Executive Summary
Two-month inspection during pandemic highlighted cross-contamination risks and process validation shortfalls at New Jersey plant.
You may also be interested in...
US FDA Warns Lupin Again About Poor Batch Failure Investigations
Agency demands review of invalidated out-of-specification findings as root causes of failures continue to elude Indian drugmaker at multiple facilities.
FDA Warns Lupin To Stop Blaming Lab And Fix Manufacturing Processes
Warning letter points to excessive in-process hold times as likely cause of out-of-specification results at two Lupin plants that the firm dismissed as outliers or blamed on analysts. FDA directs Lupin to eliminate excessive hold times and study whether they were problem.
Time Is Now To Seek US Funding, Financing To Expand Domestic COVID-19 Vaccine Supply Chain
BARDA and Development Financing Corp. officials provide insights into window of opportunity for partnering on manufacturing scale-up.