FDA Announces Plans to Resume Domestic Inspections with new Risk Assessment System
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.