14/15 June 2022
Since the beginning of the pandemic and the associated travel restrictions, inspectorates as well as pharmaceutical companies have started to carry out distant assessments/ remote audits. However, such assessments or even virtual inspections of drug manufacturers have not yet been carried out by the US FDA. This procedure has been criticised by many, as it leads to delays in the completion of inspections, the approval of drug applications or even in the removal from the so-called Import Alert List. The backlog of inspections to be carried out is now large.
Now, finally, the FDA has published a Guidance for Industry that addresses the issue. Those who hoped that this would mean that the FDA would carry out distant assessments with the same or comparable significance of an on-site inspection are disappointed. Even the title "Remote Interactive Evaluations" avoids the word inspection or assessment. A footnote explains that these remote evaluations do not meet the legal definition of an inspection. Ultimately, such a remote evaluation can only serve as a supplement to an inspection. Towards the end of the document, the possible use or benefit is described:
A company itself cannot request a remote interactive evaluation ("We will not accept requests from applicants or facilities for FDA to perform a remote interactive evaluation" the FDA states in the Guidance).
The procedure described is very similar to a virtual inspection. Interesting aspects here are, for example:
After the remote interactive evaluation, FDA will prepare a report and provide a copy to the facility, but not a Form 483 as is the case with inspections. However, there will not be a big difference, the contents are comparable and the company has 15 working days to respond in writing.