The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system.
Specifically, FDA has established a COVID-19 Advisory Rating System (COVID-19 Advisory Level), under which sites will be selected for inspection based on the state reopening phase and county level COVID-19 statistics measuring infection trends and intensification. The rating will be used by FDA to identify permissible FDA inspectional activities within specific geographic regions as follows:
To move from one inspectional phase to the next, FDA states that it must see decreasing new COVID-19 infections and hospitalizations in a given area. FDA will also take into account the availability of local services, such as public transportation.
With this rating system in place, FDA is working toward restarting inspections during the week of July 20. With the exception of retail tobacco inspections, prioritized domestic inspections will be preannounced (a notable change from past FDA practices), so that both FDA and the inspected firm may ensure a safe inspectional environment and that appropriate staff are on site. Inspectors will also be outfitted with personal protective equipment (PPE).
Impact to Regulated Firms
We suspect that FDA will work slowly and methodically in resuming its inspection program. Considering the backlog of onsite inspections that firms have been requesting to support product submissions or to close out enforcement actions, it may take some time before FDA resumes performing routine surveillance inspections. With this FDA announcement, firms that are in need of an inspection should proactively reach out to FDA to inquire about the possibility of being included on an inspection schedule.
With the resumption of FDA inspections and FDA’s new procedures, all firms should take this opportunity to reassess inspection readiness. Firms should consider the following checklist in preparation of a potential FDA inspection:
While the resumption of domestic inspections using a risk based program indicates what may be a new normal for the agency, a number of questions still remain. By example:
Given the above, FDA’s inspection processes will likely evolve, necessitating that regulated firms continue to maintain inspection readiness while also monitoring the likelihood of receiving an in-person inspector visit.
Morgan Lewis helps companies around the world prepare for FDA inspections, assist and defend inspections, and respond to inspectional observations. We provide legal and regulatory strategy and counsel on product submissions, product liability risks, and ongoing regulatory compliance.
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If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:
Jacqueline R. Berman
Michele L. Buenafe
Dennis C. Gucciardo
 See previous LawFlashes published on May 28, 2020 and March 19, 2020 concerning the suspension of the FDA inspection program.