mdi ConsultantsWe have reported previously that US FDA stopped sending their personnel to inspect foreign manufacturers in China due to widespread outbreak of COVID-19. As reported today, the FDA is now postponing most foreign inspections through April, effective immediately. However, inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.
For US-based companies, this means more FDA investigators will be available to conduct local inspections provided the US businesses stay open during the outbreak. The US companies should understand how the change in the FDA foreign inspections schedule may affect them. It is feasible the FDA will adjust its inspection schedule to increase the number and frequency of US inspections while waiting out on the foreign inspections. We recommend the companies are prepared for this possibility.
FDA will resume foreign inspections as soon as feasible.
FDA is employing additional tools to ensure the safety of products imported to the U.S. such as physical examinations and/or product sampling at our borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements and requesting records “in advance of or in lieu of” on-site drug inspections which have proved effective in the past.
The FDA will continue working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first-time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law. The FDA will be utilizing the risk-based import screening tool (PREDICT) to focus on examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce.
For additional details on this subject, please visit:
Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections
As more information becomes available, mdi will be closely monitoring the situation and will be posting more updates. If you have any specific questions regarding the coronavirus outbreak and how it may affect your company’s operations feel free to contact us via email at [email protected] RE: Coronavirus