Topic: FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic
Over the past year, the U.S. Food and Drug Administration’s approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The COVID-19 pandemic required us to rework our business operations so that we could carry out our public health mission while protecting our workforce, and the workforces of those we regulate.
Food and medical product manufacturers of FDA-regulated products generally are required to have a quality management system, known as preventive controls systems for food safety plans in the food industry, in place to ensure that their products are suitable for the U.S. consumer. The FDA conducts inspections to verify that these quality management systems are in place and operating as required, and to note and mandate corrections when they are not functioning appropriately. While on-site inspections represent a key tool, they are one part among multiple components of a comprehensive approach to the oversight of FDA-regulated products.
During the pandemic, we have prioritized inspections by identifying those that are “mission-critical” on a case-by-case basis. This means that conducting the inspection was key to our public health mission and that the activity could not be accomplished in any other way. We have done this with careful consideration of many factors, including whether products:
- have received breakthrough therapy or regenerative medicine advanced therapy designations;
- are used to diagnose, treat, or prevent a serious disease or medical condition for which there is no other appropriate substitute;
- require follow-up due to recalls, or there is evidence of serious adverse events or outbreaks, including human or animal food safety concerns; and
- are related to our nation’s COVID-19 response (e.g., drug shortages).
Due to travel restrictions imposed in response to the global pandemic—implemented both at home and abroad—traveling to sites has been challenging, if not impossible in some situations. When we have been able to visit facilities in person, we have worked hard to protect the safety of our staff and others. In some cases, FDA investigators underwent required quarantine periods in various countries for 14 days prior to starting inspections, and again when they returned home.
Topic Discussed: FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic