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# FDA Exploring Live Video Inspections During Covid
- URL: https://www.fdaweb.com/fda-exploring-live-video-inspections-during-covid/
- Published: 2020-10-16T12:00:00.000Z
- Updated: 2026-09-14T16:32:51.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147894

FDA is evaluating whether it can use live or recorded video to conduct medical product inspections as the Covid-19 pandemic continues to disrupt the agency in its inspection duties. Early in the pandemic, FDA suspended both domestic and foreign inspections, and in late July domestic inspections resumed on a limited basis. The Covid-19 pandemic has forced the agency to look at different ways to meet its responsibilities to inspect regulated industry, associate commissioner for regulatory affairs **Judith McMeekin** told the Food and Drug Law Institute’s virtual annual conference.

McMeekin said that FDA is evaluating how it can optimize its operations. “We are studying how we might incorporate new technologies and tools to support our inspections, including exploring a pilot to assess use of live or recorded video,” she said. Recently, a live video test was conducted during two produce farm investigations to determine acceptability of live technical assistance from headquarters staff and to help with targeted sampling. She said the agency is interested in expanding the pilot to drug and device facilities, and the agency is interested in receiving comments on any challenges this may present. “As we learn more from the pilot, and decide how and when we might use these and other technologies, we commit to having transparent dialogs with regulated industry as to how this may affect our procedures in the future,” she said.

For the foreseeable future, McMeekin said that prioritized domestic inspections will be pre-announced. “This will help ensure the safety of FDA employees participating in inspectional activities and the firm’s employees, providing the safest possible environment,” she told FDLI. Additionally, FDA has developed Covid-19 Advisory Rating system to help determine when and where it is safest to conduct prioritized domestic inspections. It uses real-time data to qualitatively assess the number of Covid-19 cases in a local area based on state and national data, McMeekin said. The Advisory Level is based upon the outcome of three metrics: Phase of the state (as defined by White House guidelines) and statistics measured at the county level to gauge current trends and infection intensity, she said. When each of these is taken into consideration, the agency will identify regulatory activities that can occur within the given geographic region.

Except for some mission-critical assignments, McMeekin said FDA is still not able to physically inspect most foreign-produced FDA-regulated products in the manufacturing environment. “To overcome this challenge, we are employing additional tools that have proven effective in the past,” she said. “These tools include conducting examinations and product sampling and testing at our borders, reviewing a firm’s previous compliance history, and using information shared from foreign governments.”

FDA’s Office of Regulatory Affairs is also stepping up the use of its authority under Section 704(a)(4) of the federal Food, Drug, and Cosmetic Act to request records in advance or in lieu of inspections of establishments that manufacture drugs, McMeekin said. “And we are using establishment inspection reports from capable foreign regulatory authorities under the Pharmaceutical Annex to the U.S./EU Mutual Recognition Agreement,” she said. “These approaches help inform decisions related to drug approvals and shortages.

“In addition to these records requests,” McMeekin continued, “ORA is exploring the use of a remote regulatory assessment program, and we hope to work with industry to use this approach for programs where the 704(a)(4) records request authority does not explicitly apply. This new approach would involve a remote review of records that a firm is required to maintain for the FDA’s review. The remote review could be used to help determine whether a firm complies with regulatory requirements. In general, the information obtained from such remote review could inform further follow-up by the FDA, and may allow us to focus and limit time needed on an onsite inspection or advance the inspection to a later date.”