The U.S. Food and Drug Administration (FDA) has resumed its unannounced foreign inspections program in India, yet it remains paused in China due to COVID-19 restrictions. The short unannounced and short-term inspections pilot program will begin as part of a 2021 appropriations bill. The program faces two main challenges that the FDA will have to consider and work around:
- Transportation Challenges – unreliable local transportation, access to “special economic zones”
- Staffing Challenges – funding issues, foreign travel
Although the FDA never stopped conducting foreign mission-critical inspections, they are now expanding their scope to include non mission-critical inspections. Plans to resume in February were sidelined due to COVID-19 variants.
Unannounced FDA inspections have started in India, not China
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