The COVID-19 pandemic is one of the largest public health challenges in human history. It led to the U.S. Food and Drug Administration (FDA) choosing to pause most inspections and adapt for mission-critical work on a case-to-case basis.
According to the FDA, the agency inspects a variety of fields and sectors, in particular, those related to food, medical materials and medical supplies products. There are three types of inspections: (1) for-cause (investigate a problem or complaint or the belief that there is a serious issue); pre-approval/pre-market/pre-license (part of the review of the process to market a new product); and routine surveillance (monitor ongoing compliance with the existing requirements). Out of these, the routine surveillance is being given a lower priority unless something critical and threatening to public health occurs. For example, tobacco is currently considered a low priority, while food and medications are given a higher significance.
In March 2020, the inspections were halted with the exception of mission-critical inspectional work. The mission-critical inspections that continued involved the following: products received breakthrough therapy or regenerative medicine advanced therapy, product requires follow-up because of recall, serious adverse events or outbreaks due to foodborne illness; product is used to treat a serious condition and has not substitute; product is related to the response to COVID-19.
FDA has published a guidance of the use of remote interactive evaluation last April. (2) The main strategies for the pandemic have been adapting and prioritizing, which has involved the use of existing authorities and tools for remote oversight and developing new tools to extend the organization reach. Prioritizing has involved establishing prioritization plans by type of commodity and also an overall approach that would guide the decision-making process at an organizational level.
In July 2020, the FDA resumed domestic inspections, though setting strict priorities with the use of the COVID-19 Advisory Level (3) that tracks real-time data and assess state levels.
Notably, on May 5, 2021, the FDA has issued a new report: “Resiliency Roadmap for FDA Inspectional Oversight”. (4) The Resiliency Roadmap details the inspection and assessment of the COVID-19 pandemic and the plan for priorities and operations going forward, taking into account the continued uncertainty of the pandemic and the different possibilities concerning how it will develop in the next months.
Specifically, the FDA plans three realistic options to prioritize inspections based on the current and future state of the COVID-19 pandemic:
1. Base-Case as a gradual return to standard operations,
2. Best-Case as an immediate return to standard operations, and
3. Worst-Case as a maintenance of an emergency-operations status.
Since March 2020 to March 2021, FDA has conducted 440 application-based inspections. 68 applications were delayed and are to be completed in 2021. There were 90% of for-cause inspections in 2020. FDA also carried out 821 mission-critical inspections. 29 were done outside the U.S. There were 777 prioritized domestic inspections.
The organization has taken other steps to ensure compliance and safety, including:
Reviewing records and information;
Doing remote assessments for individual program areas (around 1,183 remote assessments conducted since March 2020 to March 2021);
Using information shared by regulatory partners across state, local, tribal, and territorial lines (4,273 human food and 1,295 animal food inspections on the behalf of the FDA were ...
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