USFDA Form 483 is a list of violations, and an import alert means they banned products from that plant because the data was unreliable. In 2013, Ranbaxy admitted to falsifying drug data. As a fresh graduate, this case in our textbooks makes me furious. My own internship showed how pressure to cut costs can tempt staff to skip steps, so that admission from a big company just confirmed why we need strict quality culture, not just rules on paper.
#exams#study
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