Members of US Congress writes to FDA:Raises concerns about FDA’s India inspections Read More

The letter to FDA was written by the Republican members of the E&C committee of the US Congress Representatives and signed by Chair Cathy McMorris Rodgers and other Republican subcommittee chairs and members. The letter raised questions about the FDA’s foreign drug inspection program, in India and China. The letter also requested the FDA to provide information and data on its inspection activities and plans. The letter alleges that “FDA ended its unannounced foreign inspection program out because the agency believed it was an obstacle to deeper collaboration with India”. The letter names some of the prominent Indian Pharma companies like Intas, Aurobindo, Alembic for GMP deficiencies, product recalls. The letter challenges FDA why it does not have visibility of where API and excipients are sourced from by drug manufacturers.

The letter also asks FDA’s plans to continue inspections in China despite the expanded National Security Law of China. There has been concerns that the changes in the Counterespionage Law of China are having an impact on the GMP inspections in China by foreign bodies as the risk to auditors have increased.

Link to Letter