FDA Launches Pilot for Single Day Drug Facility Screenings (2)

The US Food and Drug Administration launched a pilot Wednesday that would allow the agency to conduct inspection assessments at domestic and foreign drug manufacturing facilities in a single day.

“The one-day inspections are a screening inspection in low risk facilities that our AI is identifying as low risk,” Commissioner Marty Makary said at the annual Food and Drug Law Institute conference in Washington. “The idea is we can do more inspections.”

“If there are any safety issues in that one-day safety screening inspections, our inspectors reserve the right to extend it,” Makary said.

The assessments are not intended to ...