Remote FDA Inspections, Records Requests, and Current Inspection and Enforcement Practices in 2022


FDA has employed numerous alternative inspection tools since the start of the COVID-19 pandemic.  FDCA § 704(a)(4) records requests, remote interactive evaluations, remote regulatory assessments, MRA reliance, and others. This survey will gather some basic information on your company's experiences with current inspection activities and with FDA's new tools, even now that on-site inspections have resumed. There will be an opportunity to provide comments to share more details on your experiences.

Responses in this survey should address the period November 2021 to present -- approximately the last 12 months.

"Some guess. Others do a survey."    Author Unknown


This survey will take between 5 and 8 minutes, depending on how broad your recent inspection experiences are and whether you provide comments, detailed comments, or no comments at all.

PLEASE SHARE the survey link with industry colleagues that may have an interest in or knowledge of this topic.

This survey is completely ANONYMOUS -- if desired.  Not even IP addresses will be captured.  The only information we are interested in is the data you share regarding inspection practices.  We will ask demographic information (company size, position level, etc) and this is helpful for result interpretation but also not mandatory.  

We will be sharing the survey results publicly.  However, IF you wish, you can receive a copy sent to your email by providing us with your email address at the end of the survey/.  This is not mandatory and you should be able to find the results elsewhere after they are compiled.  We would however, welcome the opportunity to get to know you a bit better, and we promise if you provide your email address, we will only contact you infrequently and you can always stop communications.

There are 17 questions in this survey.