I looked up what those laws referred to are, and... this is very very serious and Theranos is unlikely to survive it.<p>The first two laws they are cited as having broken are about quality control standards. The next two laws they are cited as having broken are about qualifications that must be held by the laboratory director and technical supervisor. The last law they are cited as having broken is about qualifications that must be held by technicians. They have ten days to come into compliance, but in order to address these violations they will have to either hire new staff for key leadership and other positions, or pull their product from the market. They will do the latter.<p>This same company was previously forced to pull their &quot;nanotainer&quot; testing system from the market because when regulators sent them control samples, they fraudulently tested them on different equipment and with different procedures than they used with patient samples. I will be surprised if no criminal charges are brought against Theranos CEO Elizabeth Holmes.