STAT+: ‘A cascade of failures’: FDA cites Indian drugmaker for numerous quality control problems

In a stunning rebuke, the U.S. Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses.

The agency cited Intas Pharmaceuticals for several violations of so-called good manufacturing practices, including problems with data integrity, standard documentation practices, accuracy, reproducing test methods on products, and procedures designed to prevent microbiological contamination, according to a 36-page report posted online by the agency following a plant inspection late last year.

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