In a stunning rebuke, the 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.
Notably, the FDA inspectors “found a truck full of transparent plastic bags containing shredded documents and black plastic bags mostly containing documents torn randomly into pieces by hand and mixed with other scrap materials. This truck was found about 150 meters away from the facility, waiting for the clearance to remove the scrap material.”
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