FDA Announces Plans to Resume Domestic Inspections with New Risk Assessment System

July 16, 2020

On Friday, July 11th, Stephen Hahn, MD, Commissioner of the FDA, issued a Coronavirus (COVID-19) Update, announcing the Agency’s plans to resume “prioritized domestic inspections of FDA-regulated facilities and other associated activities.”

In his announcement, Dr. Hahn states that FDA has been thoughtfully and deliberately planning the safest and most appropriate time for this to happen since the postponement was initially announced in March of this year.  Furthermore, he also notes that FDA developed its plan using The White House Guidelines for Opening Up America Again as a roadmap to optimize operations and work arrangements, as well as the Centers for Disease Control and Prevention (CDC) guidance related to protecting workforce exposures to the virus in non-healthcare settings.


On March 18, 2020, Dr. Hahn announced that FDA would be pausing all on-site inspections in the US in an attempt to keep the workforce healthy in the midst of the global COVID-19 pandemic.  However, in his announcement last week, Dr. Hahn states that FDA’s investigators “have conducted mission critical inspections and other activities to ensure FDA-regulated industries are meeting applicable FDA requirements.”  Additionally, he states that the Agency has had “great success by using a number of tools as part of its risk-based approach to ensuring quality, including remote assessments and import alerts as well as other compliance requirements.”

FDA’s New Risk Assessment System Allows Domestic Inspections to be Resumed

FDA plans to resume prioritized domestic inspections starting the week of July 20, 2020.  The Agency will use “data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments” to determine inspection locations.  In order to move forward with inspections in a given area, Dr. Hahn states that the number of new COVID-19 cases and hospitalizations must be trending downward.  Furthermore, inspection resumption will also depend on the availability of other services that may have been impacted by the pandemic, such as public transportation.

Upon resumption, one of the biggest differences will be that, for the foreseeable future, prioritized domestic inspections will be pre-announced, rather than random “surprise” visits.  This is simply to ensure the safety of both the investigator as well as the firm’s employees, and also to ensure the appropriate staff are on-site and available to assist FDA staff with inspection-related activities.  However, as with most rules, there is an exception:  retail tobacco inspections will not be pre-announced when they resume due to the nature of FDA these inspections.

With less than one week until FDA resumes its domestic prioritized inspections, it is critical that you are prepared.  Although FDA will be announcing its plans to visit and inspect your facility, it is important that you are compliant with all applicable rules and regulations now.  Don’t wait until the last minute – mistakes happen when you procrastinate.  Need help making sure all your ducks are in a row? We can help.  To learn more about our quality and compliance services and capabilities, contact us today.

Quality & Compliance GMP

July 16, 2020

FDA’s CBER Announces Invitation to Participate in the Regulatory Site Visit Training Program

On February 2, 2016, the FDA’s Center for Biologics Evaluation and Research (CBER) published its annual invitation for biologics facilities to participate in the Regulatory Site Visit Training...

Read the Full Article
Agency Alerts

July 16, 2020

FDA Announces All-Time Low User Fee Rates for Priority Review Vouchers (PRVs)

On Thursday, September 30th, FDA announced its user fee rates for fiscal year 2022 for Sponsors using the priority review vouchers (PRVs) for the following: Tropical diseases Material threat medical...

Read the Full Article
Agency Alerts General Regulatory

July 16, 2020

Report: FDA’s Drug Review & Approval Times Reduced Drastically Since 2009

According to an infographic report from the California Life Sciences Association (CLSA), FDA approval times have decreased by nearly 50% since 2009.  The infographic, entitled “Tracking FDA Drug...

Read the Full Article