The U.S. Food and Drug Administration (FDA) on Wednesday unveiled a one-day inspectional assessment pilot to complement the agency’s standard inspections. The pilot, which was launched last month, is being conducted across multiple FDA inspectorates including biologics, clinical research programs, and medical products.

The agency has so far evaluated 46 facilities using one-day inspections as part of a broader initiative to make its inspectional resources more targeted and efficient, according to the announcement. The FDA said that the pilot will continue through fiscal year 2026, which ends on September 30, with additional one-day inspections planned.  

Most of the pilot’s one-day inspectional assessments confirmed compliance, resulting in No Action Indicated (NAI) outcomes, according to the FDA. However, the agency noted that the pilot “has also demonstrated flexibility, with some assessments extending beyond one day when significant observations were identified.”

Low-risk facilities are being selected for the pilot using criteria including product type, prior inspection outcomes, and operational characteristics, while data gathered through the one-day inspections — such as recurring compliance themes, facility-specific risk scores, and discrepancies between registered and actual operations — could impact future oversight activities...[PharmaManufacturing]