Beyond the obvious (one plant that produces majority of 1 critical product for US going offline)....
How did we get to the point where we looked at this situation and decided it was tenable (or possibly even a good idea)? I work in the Med Device industry, and a major sticking point (well before COVID) was confidence in your supply chain. Regular audits on your primary supplier and having a second source ready to go for critical components.
I also found the timeline regarding the plant kinda comical (at least as funny as this whole situation can get).
-Babies got sick and auditors descend on this manufacturing plant
-They find fault and shut down the plant
-but investigations into the baby infections show it wasn't directly due to the formula (IIRC)
-After the plant shutdown, the situation in the US goes straight to ish-show. The story on the plant is that previous audits failed to detect and/or address issues in the plant that may or may not lead to contamination
-FDA's response is to streamline the process for companies to sell formula in the US (lol). This is because one of the headlines is many formula makers standards overseas meet or exceed FDA's, but they are not allowed to sell here (probably because they don't dot a certain 'i' the way FDA wants them too... I'm paraphrasing here).
My interpretation of all that is when those babies got sick and the auditors showed up, they weren't going to leave until they bent Abbott over the table. I see this all the time... auditors act like they have to find something/anything whenever they visit your facility. With the situation being what it is, they couldn't go through that facility without any major findings. Many of FDAs processes (specifically ones related to initial submissions) are extremely archaic. It's not surprising to me in the least that there are equivalent/superior products available in the EU that can't gain FDA approval here in the US.
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