Bags of shredded docs: Indian drugmaker Lupin handed a Form 483 by FDA inspectors
The generics manufacturer Lupin has been given another Form 483 from the FDA this year.
US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.
The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.
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