> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Drug Inspections Resuming in China and India
- URL: https://www.fdaweb.com/fda-drug-inspections-resuming-in-china-and-india/
- Published: 2021-01-28T12:00:00.000Z
- Updated: 2026-09-14T16:44:30.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148546

FDA has resumed conducting “prioritized” inspections by investigator staff in China and they will begin shortly in India too, according to CDER acting director **Patrizia Cavazzoni**. In a recent Twitter posting, Cavazzoni noted that inspections deemed “mission critical” are still being conducted. “We’re prioritizing inspections so the agency will continue to meet \[user fee\] goals to the best of our ability, she said.

Cavazzoni’s comments are tied to new user fee goal statistics that showed the percentage of pre-approval inspections not conducted and other tools and approaches used instead due to the Covid-19 pandemic rose from 48% in the third quarter of Fiscal Year 2020 to 60% in the fourth quarter, which ended 9/30/20\. The Center’s latest [update](https://www.fda.gov/industry/fda-user-fee-programs/cders-work-meet-user-fee-goals-during-pandemic?ref=fdaweb.com) on application reviews and the pre-approval process during the pandemic says that due to practice constraints such as travel limitations and quarantine and physical distancing requirements or lockdowns, CDER has been relying on inspection alternatives including: 

- reviewing facilities’ compliance history;
- using information shared by trusted foreign regulatory partners through mutual recognition and confidentiality agreements;
- requesting records directly from facilities instead of on-site drug and biological product inspections; and
- sampling drugs at the border.

Cavazzoni also noted that FDA has developed a rating system (FDA Advisory Level system) to “assist us in determining when and where it is safest to conduct prioritized domestic inspections. As we navigate this challenging landscape, CDER will maintain our rigorous review standards, but will not put staff in danger. If we’re unable to do on-site inspections, we’ll take interim measures and employ additional tools to ensure safety of products imported to the U.S.”