FDA Report on Impact of Pandemic on Inspections

Recommendation

4/5 December 2024
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The U.S. Food and Drug Administration FDA has released a report entitled "Resiliency Roadmap for FDA Inspectional Oversight" that describes the agency's inspection activities during the COVID-19 pandemic. In addition, the document also includes a plan for future inspection improvements and prioritisation.

Review: In March 2020, the FDA announced it would temporarily postpone all domestic and foreign inspections while it continued so-called mission-critical inspections. This report now provides, among other things, an overview of the number of these mission-critical inspections, but also of other approval-related and routine inspections.

Interesting facts:

From March 2020 to March 2021, the FDA conducted a total of 821 mission-critical inspections (29 of which were overseas). However, most of these inspections were conducted in the area of food and bioresearch monitoring. For "Human Drugs", there were just 49 inspections performed in the specified period.
777 prioritized domestic inspections were carried out, 106 of which were in the area of "Human Drugs".
Of the more than 13,500 applications submitted for medical product approval or authorization received since March 2020, it is estimated that 68 applications (48 of them for "human drugs") have been delayed because inspections could not be carried out (most of them are not considered mission-critical).
In addition, the report provides an overview of FDA's use of alternative tools and approaches when inspections were or are not possible, including "remote interactive evaluations", e.g. live video streaming of operations, teleconferencing, or use of screen sharing).

The report also describes current activities to resume normal operations of inspection activities, including how FDA intends to prioritize domestic and foreign inspections that were not conducted during the pandemic. There are several possible scenarios here as the course of the pandemic remains uncertain. Prioritization will be risk-based and mission-critical inspections will remain a priority. For less risky facilities, this may lead to delays and longer intervals between inspections.

The FDA is also establishing a so-called FDA Inspectional Affairs Council, which will plan and coordinate inspection activities. More information on this will be provided in due course.

Source: "Resiliency Roadmap for FDA Inspectional Oversight"