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US FDA Warns Intas To Assess Global Quality Following Plant’s Data Integrity Meltdown

 
• By Bowman Cox

Warning letter details extensive GMP and data integrity remediation expectations for Matoda plant and calls for the privately held generic drug manufacturer to immediately confront its corporate quality issues globally.

Microbial colony counting
the fda saw bacterial colony undercounting and much more • Source: Shutterstock

A 28 July warning letter from the US Food and Drug Administration called on Intas Pharmaceuticals Ltd. to conduct a global quality assessment now that a litany of data integrity failures agency investigators observed at one of its facilities near Ahmedabad, India, show that its corporate quality system is ineffective.

The warning letter, which lays out a sweeping remediation plan for the plant, located southwest of Ahmedabad near Matoda Village, concluded that the firm’s executive management “should immediately and comprehensively assess your company’s global manufacturing

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