FDA Scales Back Domestic Inspections

March 18, 2020

FDA postpones routine domestic facility inspections due to the COVID-19 pandemic.

FDA announced that the agency will temporarily postpone all domestic routine surveillance facility inspections, those conducted every few years based on a risk analysis. In a March 18, 2020 statement, FDA Commissioner Stephen M. Hahn said the agency will evaluate all domestic for-cause inspection assignments and “will proceed if mission-critical.” On March 10, 2020, FDA announced a postponement of foreign inspections.

“I want to assure the American public that we have full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate," Hahn said in the statement. The agency will take steps such as evaluating records in lieu of conducting onsite inspections.

“From our experience across the agency, we also believe FDA-regulated firms understand and appreciate their shared responsibility to ensure the integrity of the supply chain, and we will continue to communicate with them during this time to underscore this partnership,” Hahn said in the statement.

Source: FDA