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The Quality Lowdown: Blast From Past At Sun Mohali, Touch Of Future With IT/OT Integration

 
• By Bowman Cox

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.

The Quality Lowdown

Data integrity shortcomings in drug manufacturing at a former Ranbaxy Laboratories Limited plant that the US FDA discovered nearly two decades ago thanks to help from whistleblower Dinesh Thakur led to a consent decree in 2013 that the US Food and Drug Administration has invoked anew based on inspection findings last year.

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More from Compliance

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
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US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

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US Pharma Tariff Reprieve May Be Ending

 
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