They have been "looking" since 2012 - and between 2012 and 2015 did - in effect - nothing else than looking. They did not shut down anything - Theranos pulled back when the FDA requested a change of classification from I to II. When you have the auditing power of the FDA, you should have the ability to do better than request a "change of classification" in 3 years when you have so much evidence of fraud.

https://www.washingtonpost.com/news/wonk/wp/2015/12/02/inter...

For the other point - the FDA has oversight into R&D when human are concerned - even if the requirements are not the same than for market clearance.