FDA Scales Back Domestic Inspections

In keeping with the White House Coronavirus Task Force and cross-government guidance, this week FDA directed all eligible employees to begin teleworking. This does not apply to those carrying out non-portable activities, such as certain lab activities or the monitoring of imported products. The FDA continues to adjust its approach to a number of activities, including facility inspections for all FDA-regulated products.

Earlier this month, the FDA said it was postponing most foreign facility inspections through April and that inspections outside the U.S. deemed mission-critical will be considered on a case-by-case basis as this outbreak continues. Learn more here.

As of today, the FDA has temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. The FDA says it will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products.

During this interim period, the FDA is evaluating additional ways to conduct inspectional work that would not jeopardize public safety and protect both the firms and the FDA staff. This can include evaluating records in lieu of conducting an onsite inspection on an interim basis when travel is not permissible, when appropriate.

The FDA says inspections are just one part of a robust and multi-pronged approach to oversee the safety and quality of FDA-regulated products, however inspections are not what cause quality to happen. Safety and quality need to be owned by the industry, and firms have the primary responsibility to reliably produce quality products. For example, medical product industries are subject to certain reporting requirements about their facilities and also must adhere to Current Good Manufacturing Practice (cGMP) requirements pertaining to operating procedures, manufacturing, sanitation, and processing controls, as well as preventive controls to reduce or eliminate safety hazards.

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