FDA to Begin GMP Inspections Next Week, Sort of.
[Thursday, July 16, 2020]

FDA announced earlier this week that the domestic GMP inspections would commence on Monday, 20 July. However, there would still be several conditions that must be met before FDA inspectors travel to a manufacturing site and FDA would allow several concessions to the site being audited such as no-unannounced visits, using PPEs during the visit and allowing people at the site to be remotely interviewed. In March FDA had suspended on-site inspections due to the pandemic and announced focusing on alternate means to verify quality. Those practices will continue to the extent needed. Prior to inspection, the location of the site must have downward trends in new Covid cases and hospitalizations, must follow local and state guidelines, and public transport must be available. Manufacturing sites that are working on reduced staff or have reduced and altered operations due to the pandemic will be given considerations. In general, FDA inspectors would follow CDC guidelines but will adjust to any reasonable requests from the site. In many regards, the inspection process will not change, just use extra precautions to protect the inspectors and the audited location. It is not public if FDA has any internal policies for its inspectors who do not feel comfortable traveling or visiting sites for inspection. It is also not clear if the inspectors would allow themselves to be tested for Covid prior to entry into the site being audited. Most regulated sites have implemented special measures to address the pandemic. Common sense says that inspectors would comply with most reasonable requests for extra precautionary measures at the site being audited. In practice, FDA inspections are still not going to resume full-speed and probably be limited to specific violations rather than routine surveillance. And non-US inspections are probably not resuming this year.