FDA halts domestic inspections, calls for industry to ‘own’ quality

In a statement by the commissioner of the US Food and Drug Administration (FDA), Stephen Hahn announced that the agency would no longer carry out physical inspection of domestic facilities. Additionally, all employees eligible to telework were now doing so.

The commissioner stated that the decision to cease domestic inspection was made for the health and well-being of the agency’s staff, as well as concerns expressed by the industry over visitors to sites.

However, Hahn noted that inspection assignments would be evaluated and will proceed if ‘mission critical’.

This was the same conclusion that the FDA came to when it announced last week that it would cancel foreign site inspections​, making an exception only for those cases that were deemed to be a priority.

In place of physical inspections, the FDA outlined that it will evaluate records from facilities, among over methods. However, Hahn stressed that the onus will be on industry to ensure the safety of products.

“Safety and quality need to be owned by the industry and firms have the primary responsibility to reliably produce quality products,”​ he stated.

Hahn furthered that from the agency’s experience, FDA-regulated firms ‘understand and appreciate’ this responsibility, and that “we will continue to communicate with them during this time to underscore this partnership.”​

The FDA highlighted that of all facilities in the US only 5% had violated safety or quality, which it highlighted as a sign of broad compliance across the industry.

In terms of when inspection may resume, the agency only stated that it is ready to resume its activities ‘as soon as feasible’.

Regulators around the world are having to adapt processes rapidly to the spread of the novel coronavirus, with developments occurring daily​. However, at present, the FDA has only noted one product in short supply​ as a result of the virus’ impact on production.