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 swift manner, allowing for contaminated generics to reach vulnerable patients in the U.S. In dozens of letters to the agency, Sun Pharma vowed fixes to the facility along with staffing, quality, standards and training.
The drugmaker also had pledged $218 million in facility improvements, according to one letter shared with the FDA. However, in 2016 inspectors found more problems at the facility. The drugmaker also had reassured the agency of the safety of Parkinson’s drugs carbidopa and levodopa, which were having trouble dissolving properly when ingested. Sun Pharma said it was working on an internal review to assess other drugs. Soon after, the company issued a recall for 8,500 bottles of the medications in the U.S.
In the most recent FDA inspection in June, inspectors found the facility failed to look into bacteria found in the test vials and properly disinfect manufacturing areas. Though the agency published warning letters on its website to the drugmaker, the public was not notified through any alerts.
