FDA To Resume Onsite Foreign Inspections After Hitting Domestic Goals

FDA conducted twice as many domestic facility inspections this year than it had previously planned, yet 60 applications are still on hold awaiting onsite inspections, 90% involving foreign facilities and four of which are mission critical, the agency reveals in an inspection roadmap update issued this week . FDA plans to resume priority onsite foreign inspections, including surveillance and application-related ones, beginning in February 2022 if it is safe to travel internationally. As for domestic inspections, FDA will use risk...