Remote Inspections: Stakeholders Seek Clarity As Some At US FDA Struggle With Process

Some lawmakers want FDA to prioritize in-person visits, but others are complaining that more remote inspections are needed because approvals are being delayed.

technician in pharmaceutical factory
Stakeholders are pushing the FDA to resume in-person facility inspections. • Source: Alamy

Some US Food and Drug Administration staff continue to struggle with remote inspections as stakeholders press for greater use of the pandemic work-around to reduce a growing backlog of facilities waiting for the visits.

Lawmakers wondered during a House Energy and Commerce Health Subcommittee hearing earlier this month how alternative inspection tools can be used more effectively, including for generic and biosimilar facilities

More from Manufacturing

More from Compliance