FDA: Delays in Resumption of Inspections

Recommendation

5/6 October 2023
Heidelberg, Germany

Quality Culture
People Empowerment in GMP

The FDA announced in its FDA Roundup of 4 January that the agency is adjusting its planned inspection activities to the developing COVID-19 pandemic and the spread of the Omicron variant. The agency has therefore temporarily postponed certain inspection activities in the hope of resuming them as soon as possible.

The FDA will continue to conduct so-called mission-critical inspections in the US and abroad, but will reassess plans to do so as needed. The agency is also postponing plans for surveillance inspections abroad, which were supposed to begin in February 2022.

In doing so, the FDA will continue its type of "remote foreign supplier verification programme activities" to maintain surveillance of food, drugs, medical devices and tobacco products. Last year, the FDA published a Guidance for Industry that addressed this issue. However, those who hoped that this would enable the FDA to carry out remote evaluations with the same or comparable significance of an on-site inspection were deceived. Even the title "Remote Interactive Evaluations" avoided the word inspection or audit. A footnote explained that these remote evaluations do not meet the legal definition of an inspection. Ultimately, such a remote evaluation serves as a supplement to an inspection. The procedure described is very similar to a virtual inspection, so "livestreaming walkthroughs of the facility" and interviews can be conducted. Following the publication of the above guidance, FDA then updated its Question and Answer document, "Manufacturing, Supply Chain, and Drug and Biological Product Inspections during COVID-19 Public Health Emergency", which explains some of the actions to be taken when the agency cannot conduct an on-site inspection of a facility.