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US FDA hits Intas Pharma with warning letter; notes data integrity lapses at Ahmedabad plant

US FDA hits Intas Pharma with warning letter; notes data integrity lapses at Ahmedabad plant

The regulator noted that visual inspectors manipulated particle and other defect counts on records to keep the finished product batches within rejection limits Read More ​ The regulator noted that visual inspectors manipulated particle and other defect counts on records to… Read More »US FDA hits Intas Pharma with warning letter; notes data integrity lapses at Ahmedabad plant

US FDA hits Intas Pharma with warning letter; notes data integrity lapses at Ahmedabad plant

US FDA hits Intas Pharma with warning letter; notes data integrity lapses at Ahmedabad plant

The regulator noted that visual inspectors manipulated particle and other defect counts on records to keep the finished product batches within rejection limits Read More ​ The regulator noted that visual inspectors manipulated particle and other defect counts on records to… Read More »US FDA hits Intas Pharma with warning letter; notes data integrity lapses at Ahmedabad plant

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