There were actually a number of scandals out of India on this front as well:
https://www.npr.org/sections/health-shots/2019/05/12/7222165...
It's extremely hard to enforce GMP and QA/QC from across the world and there's a strong incentive to cheat and lie when it comes to these costly procedures. Whether it'll be any better in a US manufacturing facility is of course up for debate.