FDA to Resume Domestic Inspections Using New Risk Assessment System, Hahn Says

FDA Commissioner Stephen Hahn said Friday that the agency will resume domestic inspections this month using a new risk assessment system developed in response to the pandemic.

Hahn said the agency plans to resume on-site inspections the week of July 20, but he cautioned that the agency must see a downward trend in new COVID-19 cases and hospitalizations to meet this goal.

The agency’s new COVID-19 Advisory Rating System will use real-time data to assess the number of COVID-19 cases, and the inspection decisions will depend on a state’s phase of reopening and local statistics on infections, Hahn said.

The prioritized domestic inspections will be pre-announced “for the foreseeable future,” Hahn said, to ensure the safety of investigators and the firm’s employees, and to ensure the appropriate staff are present for the inspections.

The FDA suspended routine on-site inspections in late March and said it would rely on written records on an interim basis (DID, March 27). — Jordan Williams