Drugmaker Sun Pharma pledged sweeping reforms after years of persistent safety violations at its flagship manufacturing plant in Halol, India, but failed to follow through, according to FDA documents obtained by ProPublica.  The documents also showed the FDA tolerated repeated failures at the facility for more than a decade, even when inspectors found dangerous contamination, poor quality controls and adulterated drugs shipped to the U.S. The drugs included cancer treatments and injectables. 

An import ban was imposed in late 2022; however, more than a dozen drugs were exempted and could still reach U.S. patients. Another inspection was performed in June 2025, when the FDA found unsafe conditions again.  Experts, including some former FDA inspectors, said the agency failed to act in a swi

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