FDA reports rise in unannounced drug inspections in China and India for FY 2026

A senior FDA enforcement official said the agency carried out more surprise drug facility inspections in India and China during fiscal year 2026 than it did in the prior year.

The unannounced visits are part of the FDA’s effort to verify that overseas manufacturers meet U.S. safety and quality standards for products destined for the American market.

Companies with production sites in the two countries may need to review their compliance programs and be prepared for additional scrutiny, which could affect timelines and costs for drug shipments to the United States.