US FDA Warning Letter Questions Takeda’s Support For Quality
Aseptic processing lapses signal deeper problems at Takeda’s Hikari plant.
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The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.
Tuberculosis or cancer, sterility assurance or shortages, the choices come at you fast; Takeda, Wintac, Banco Vida updates.
Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.