FDA Inspections Remain on Hold Due to COVID-19
The US Food and Drug Commissioner Stephen Hahn provided an update on FDA surveillance inspections during the COVID-19 pandemic.
The FDA “will continue to utilize and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections,” said Hahn in a May 11, 2020 statement. “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 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.”
Hahn reported that the FDA is collaborating with the Centers for Disease Control and Prevention 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,” said Hahn in the agency’s statement. “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.”
Hahn said that the FDA is in regular contact with industry and the agency’s international counterparts to evaluate the situation with respects to inspections. “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,” he said in his statement. “…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.”
Source: US Food and Drug Administration