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We may need nearshore/onshore QC

That's how the FDA operates.

That's why the filing above was created by the FDA.

You'll have some level of surprise inspections in India, and another set when the batch is imported to the US or EU.

That is not how the FDA operates. For more than 2 decades, the FDA has basically given these overseas generic factories months of advanced notice of inspections. There are even former inspector who tried to whistleblower over how many times theyve caught those factories fabricating data and other circumstnaces and the FDA just buried the issue.

The real question, what in the world changed that made the FDA decide to suddenly cause the effective discontinuation of chemo as a treatment option for the US LOL

Its ok to subsidize banks in the US, but we can't subsidize manufacturing (like every other country) for some reason.

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