A Brief Introduction About FDA Next Step Inspections

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 conducted in 2020-2021);

• Using information shared by trusted foreign regulatory partners;

• Sampling and analytical testing of regulated products domestically and at the international borders (65 foreign establishments placed on import alert);

• Refusing entry of unsafe imported products.

Due to the ongoing and uncertain nature of the pandemic, FDA continues to prioritize the mission-critical inspections and has outlined plans that depend on how the situation with COVID-19 develops, considering the best and worse case scenarios. They will continue to carry out other types of inspections. Postponed inspections will be conducted over a longer period of time and based on risk assessment. The biggest challenge is managing the large volume of inspections that fall into the lower priority tiers that the FDA will try to resolve going forward.   

FDA’s fiscal year ends in September 2021, and this is taken as a benchmark date to achieve the plans and objectives that the agency is currently facing. According to the report, there are 12,285 human and animal food inspections remaining for the fiscal year 2021, with 1,272 (10%) of these inspections achievable under the base-case scenario and 2,579 (21%) achievable under the best-case scenario. The agency will focus on mission-critical inspections under the worst-case scenario.

In regards to surveillance inspections, there were plans to complete 21 thousand establishments in 2020. 8 thousand were postponed due to the pandemic. 2021 involves a plan for 26,250 inspections, including those that were delayed. However, the rate at which the inspections will take place depending on how the pandemic situation will continue to develop and whether the situation will continue according to a best-case or worst-case scenario.

However, for future inspections, the institution intends to continue to use the remote tools (2) and authorities they relied on during the pandemic to improve operations and strengthen overall compliance. In the worst-case scenario, these tools would be prioritized, but they are considered in regards to all three options.

However, for future inspections, the institution intends to continue to use the remote tools and authorities they relied on during the pandemic to improve operations and strengthen overall compliance.

FDA is currently expanding its workforce and will begin a modernization effort that will transform infrastructure and data enterprise, integrating next-generation technology and tools and overall improvements. FDA is also working to increase the speed of the evaluations and integrate the new tools to help build a more flexible, data-driven, and risk-based oversight modeling system. FDA intends to maximize every approach and resource to accomplish its mission. 

While the pandemic continues, the efforts will be focused on mission-critical and prioritized inspections. Lower risk inspections and routine inspections will be delayed and given a lower priority until normal operations are resumed, and this is a decision based on risk assessment. The safety and well-being of FDA staff who have been having difficulties accessing administrative leave are also considered a priority. FDA expresses and reinforces its commitment to protecting public health and regulating products that can represent a risk within the U.S. which may help guide the new and next step inspections.

References

1. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-classification-database

2. https://www.fda.gov/media/147582/download

3. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-prepares-resumption-domestic-inspections-new-risk-assessment-system

4. https://www.fda.gov/media/148197/download

Author: Lin Zhang

Date: Jun.19,2021

About the Author:

Lin Zhang, M.D., senior director of a health care industry company in the United States. With the experience in clinical medicine, biotechnology, health industry and other fields, he is responsible for the research and development of plant medicine, functional food and health products. He was a clinician and worked for the National Cancer Institute, FDA and the National Cancer Center of Japan for many years.