3 ms·
The FDA has to give the factories 90 days notice of an upcoming inspection.
by RachelF 2y ago
The FDA has to give the factories 90 days notice of an upcoming inspection.
- hiatus 2y agoThat is crazy. Restaurants don't get any notice for health inspection, why are drug factories treated differently when the risks are larger? edit: The parent comment is flat-out incorrect. Not sure where you are getting your information from. > FDA inspections are generally unannounced, with a few exceptions. From FDA's "What to expect during an FDA inspection" https://www.fda.gov/media/142762/download https://www.fda.gov/media/142762/download
- hyeonwho4 2y agoAs of 2022, foreign inspections were generally preannounced, and the GAO identified the need for a "pilot plan" for surprise foreign inspections: https://www.fiercepharma.com/pharma/fda-must-solidify-plan-for-unannounced-foreign-inspections-rev-up-hiring-overseas https://www.fiercepharma.com/pharma/fda-must-solidify-plan-f...
- hiatus 2y agoI appreciate the additional information, though to the point it does not seem that FDA is _required_ to give any notice before an inspection.