LATYPOVA: There are no requirements for inspection of biologics manufacturing facilities by the FDA. This requirement was removed by Scott Gottlieb [per] admin rule change in 2019. Whatever is being produced is entirely open to adulteration, and this applies to all biologics, not just COVID

There are no requirements for inspection of biologics manufacturing facilities by the FDA. This requirement was removed by Scott Gottlieb as admin rule change in 2019. Whatever is being produced is entirely open to adulteration, and this applies to all biologics, not just covid… pic.twitter.com/EoQmMYVh3r

— sashalatypova.substack.com "Due Diligence and Art" (@sasha_latypova) June 15, 2024

Elaborated here at Sasha Latypova's Substack.