HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


In-Person Inspections Remain US FDA’s Preference Despite ‘Virtual’ Options

Executive Summary

US FDA continues to see in-person inspections as more efficient and more effective than ‘virtual’ alternatives. And that means that almost all domestic inspections will be handled by traditional site visits.

You may also be interested in...

US FDA Sets Post-Pandemic Expectations For Manufacturer Remote Interactive Evaluations

Draft guidance outlines how the agency will use RIEs as COVID-19 becomes endemic and agency staff are generally able to travel for site inspections – and how manufacturing facilities should prepare for them.

Congress Wants Answers From US FDA On India And China Inspection Plans

House Republicans keep the pressure on the US FDA for plans to catch up on inspections after the long COVID-19 hiatus. Recent cancer drug shortages could be a headline event to lead into a larger probe.

FDA Avoided Half Of ANDA Pre-Approval Inspections During COVID By Using Alternative Tools

Records reviews are common now in lieu of an in-person inspection for US generic applications, but more virtual facility checks could be coming soon.


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts