FDA introduces one-day inspections for more effective oversight

The U.S. Food and Drug Administration announced the launch of a pilot program for one-day inspections, aimed at making oversight more effective and better targeted toward risks. This was reported by the regulator.

The new approach, introduced in April, includes shorter and more focused inspections that complement the agency’s standard inspections. The goal is to cover more facilities in less time without compromising regulatory requirements.

“One-day inspections can strengthen our approach by directing time and resources where they are most needed,” said FDA Commissioner Marty Makary. “This allows for broader surveillance and the collection of key information without disrupting the rigor of oversight.”

According to him, this model also benefits businesses as it provides faster feedback and reduces operational burdens, especially for lower-risk facilities.

One-day assessments will also support the development of more precise risk assessment models. The data collected – including recurring violations, specific risk indicators for facilities, and operational discrepancies – will be used for better planning of future inspections.

The pilot program covers various areas of activity, including human and animal food, biological products, medical devices, and clinical trials. Facilities are selected based on risk criteria such as product type, previous inspection results, and operational characteristics.

By the end of April 2026, the FDA had conducted approximately 46 such one-day inspections. In most cases, compliance with requirements was confirmed, and no violations were found. In individual cases, inspections were extended when more serious issues were discovered.

The agency emphasizes that this new type of inspection will not replace standard inspections but will complement them. Inspectors retain the right to expand the scope or duration of inspections if necessary.

“We are carefully analyzing the data collected to evaluate how this approach can improve our overall oversight strategy,” said Elizabeth Miller, FDA Assistant Commissioner for Inspections and Investigations.

The pilot program will continue throughout fiscal year 2026, with more inspections planned. The agency is also developing performance metrics, including inspection duration, frequency of inspection expansions, and the utility of the information collected for decision-making.