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.
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US FDA Balances Urgent Need For Platinum Chemotherapies Against Intas Plant’s Quality Failures
As politicians demand help for cancer-ridden constituents, the agency allows Indian plant that flunked inspection to resume exporting batches of cisplatin and carboplatin to the US, but only after passing independent 45-day batch certification reviews.
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.
Why Generic Drug Manufacturing Is Faltering And Ways To Bolster It
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