FDA Updates Inspections Information During COVID-19

13 May 2020

GMP News

During COVID-19, the U.S. Food and Drug Administration will continue to utilize and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections. This will continue as local, national and international conditions warrant, with the exception of certain mission critical inspections. Mission critical inspections are identified on a case-by-case basis and conducted with appropriate safety measures in place.

While this pandemic has added new complexities to normal operations, FDA implemented alternative approaches to on-site surveillance inspections that provide with useful information toward fulfilling the agency’s mission.

The FDA is collaborating with the CDC to develop a process that would govern how and where to return to on-site facility surveillance inspections in accordance with the gating criteria outlined in the White House Guidelines for Opening Up America Again. Expected this to be a phased approach driven by scientific data.

Although inspections are critical, they are one part of a robust and multi-pronged approach to overseeing the safety and quality of FDA regulated products. Safety and quality must be part of the daily routine at any regulated facility for their products to be high quality and reliably suitable for the U.S. consumer.

Most FDA-regulated firms understand and appreciate their responsibility to ensure the safety of the products they manufacture or produce. The FDA’s regulatory oversight of crucial industry sectors is vital to the long-term health of America, but product safety and quality are ultimately the establishment’s responsibility and most firms strive to reliably provide quality products and maintain the integrity of the supply chain.

FDA’s leadership team meets daily to discuss the urgent issues facing us as we facilitate efforts to diagnose, treat and prevent the disease; survey the medical and food product supply chains for potential shortages or disruptions and help to mitigate such impacts, as necessary; and leverage the full breadth of our public health tools.

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