How the hell does US FDA have so much control over a foreign country's pharma factories? US is not even the biggest market out there.
Well a couple of things:
(1) if the FDA (even on trivial grounds) blocks certain factories then you cannot ship product from then to the US market. Also the FDA will with-hold new product approvals until the issue is resolved. Both actions lead to a big loss
(2) Many countries do not have their own well staffed regulatory agency and follow the FDA lead. So more loss
(3) It seems that FDA inspectors can get vindictive (on their own, or US deepstate pressure, or foreign deepstate pressure through the US agents)... so additional issues
So FDA and EMEA (EU) et al are GOD as far as a private company is concerned.
Even India mostly FDA lead (e.g. ban of Vioxx a COX-2 inhibitor in 2004 by FDA lead to an almost simultaneous ban in India). It was actually a Fabulous drug but trial lawyers in the US claimed that it caused a small increase in cardiovascular incidents... which it did in a roundabout way ... normal NSAIDs (Aspirin, Ibuprofen etc) are slightly protective and when comparing against Vioxx there is a slight increase for Vioxx
So a big loss for those in need of that pain relief. India could have done its own thing... and can still bring it back...but no