Coronavirus (COVID-19) Update: FDA updates on surveillance inspections during COVID-19
- For Immediate Release:
- Statement From:
Stephen M. Hahn, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( December 2019 - January 2021 )
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.
In this unprecedented time, we are working hard to help ensure the safety and integrity of the products we all need, while striking an appropriate balance between a scaled back surveillance inspection program and the continuation of providing robust regulatory oversight. While this pandemic has added new complexities to our normal operations, we have implemented alternative approaches to on-site surveillance inspections that provide us 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. We expect this to be a phased approach driven by scientific data. Our priority and commitment are to first protect the health and well-being of not only our own highly skilled workforce and state contract inspectors, but also the health of workers in the important industries we regulate.
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.
Based on decades of experience with our diverse regulated industries, we believe most FDA-regulated firms understand and appreciate their responsibility to ensure the safety of the products they manufacture or produce. We consider these firms to be our partners in public health. 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. Most firms strive to reliably provide quality products and maintain the integrity of the supply chain. We are in steady communication with our industry partners as well as our domestic and foreign regulatory counterparts to assist them during this difficult time.
Our 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. We continue to closely monitor the global situation and remain in contact with our domestic and foreign regulatory counterparts to inform our assessment of the feasibility of a return to routine on-site surveillance inspections as conditions improve.
The FDA is confident in our ability to maintain oversight during this pandemic by leveraging all available authorities, alternative tools, and scientific methods to ensure the integrity and availability of safe and quality products for the American people.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Jeremy Kahn