US FDA: Sun’s Mohali Plant Dropped Ball On Worker’s Data Integrity Allegations
Was backdating of GMP records part of an effort to move suspect product? FDA investigators found Sun was leaving lots of stones unturned in its effort to find out.
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The Quality Lowdown: Blast From Past At Sun Mohali, Touch Of Future With IT/OT Integration
Ranbaxy consent decree is invoked again after the FDA’s latest inspection unveils backdating at Sun’s Mohali plant. FDA probes Intas plant’s many deceptions, Ipca stumbles on investigations without start dates and Sure-Biochem must admit missing client’s contamination.
Ranbaxy Whistleblower’s New Mission: How to Detect Fraud from Afar
A decade ago, Dinesh Thakur was able to perceive data integrity issues at Ranbaxy because of his unique position in the company. Today, he’s working to help pharmaceutical companies monitor their global manufacturing networks to detect such issues wherever they might occur.
Confronting Illusions of Quality in Indian Generics Manufacturing
A sharp increase in data integrity findings has raised questions about the quality of pharmaceutical manufacturing in India. What’s happening and why, who’s responsible, and how can drug makers and the regulatory agencies that watch over them put a stop to it?