<sod>On October 28, 2015, the [[Food and Drug Administration]] (FDA) also reported major shortcomings in the company's practices and ordered Theranos to stop using its Edison device, which it had neither tested for accuracy nor approved, contrary to the company's previous claims.<ref>{{Cite news|title = FDA Inspectors Call Theranos Blood Vial ‘Uncleared Medical Device’|url = http://www.wsj.com/articles/fda-inspectors-call-theranos-blood-vial-uncleared-medical-device-1445967607|newspaper = [[Wall Street Journal]]|access-date = 2015-10-29|issn = 0099-9660|first = John|last = Carreyrou}}</ref> The [[Arizona Department of Health Services]] reported issues in the company's other laboratory.<ref>{{cite web|url=http://www.usatoday.com/story/tech/nation-now/2015/11/30/arizona-inspectors-find-theranos-lab-issues/76588902/|title=Arizona inspectors find Theranos lab issues|date=30 November 2015|work=[[USA TODAY]]|accessdate=26 December 2015}}</ref> Several [[clinical pathologist]]s and other medical experts also expressed skepticism about Theranos's technology. A week later, the [[Food and Drug Administration]] (FDA) stated that the company's miniature blood containers were unapproved for any test other than the [[herpes]] test. Subsequently, Theranos was ordered to limit the use of its proprietary technology to only one of the 200 tests offered by the company.<ref name="NYT_James_2015" >{{cite web|url=http://www.nytimes.com/2015/10/30/business/the-narrative-frays-for-theranos-and-elizabeth-holmes.html|title=The Narrative Frays for Theranos and Elizabeth Holmes|date=October 30, 2015|work=The New York Times}}</ref><ref name="Dan_Fortune_2015">{{cite news |url=http://fortune.com/2015/10/15/theranos-unicorns/ |title=Theranos controversy has little to do with 'unicorns' |author=Dan Primack |date=October 15, 2015 |work=Fortune}}</ref><eod>
<sod>The Food and Drug Administration received a formal inquiry to look at Theranos blood test devices by the Department of Defense in 2012 before the devices were commercially available and did not require FDA approval.<ref>{{cite web|url=https://www.washingtonpost.com/news/wonk/wp/2015/12/02/internal-emails-reveal-concerns-about-theranoss-fda-compliance-date-back-years/?tid=pm_business_pop_b|title=E-mails reveal concerns about Theranos’s FDA compliance date back years|author=Carolyn Y. Johnson|date=2 December 2015|work=[[Washington Post]]|accessdate=26 December 2015}}</ref> FDA inspection reports from 2014 and 2015 stated that its containers for blood collection were "not validated under actual or simulated use conditions" and "were not reviewed and not approved by designated individual(s) prior to issuance."<ref>{{Cite news | title =  The FDA's notes from its visit to Theranos' labs don't look good  | work = Business Insider | date = 27 October 2015 | accessdate = 2015-10-27 | url=http://www.businessinsider.com/fda-documents-on-theranos-2015-10}}</ref> After the inspection, Theranos announced that it would voluntarily suspended its tests apart from the FDA approved herpes simplex virus (HSV-1) test.<ref>{{cite web | url=http://www.techtimes.com/articles/98407/20151022/blood-testing-start-up-theranos-is-in-pause-period-says-ceo-elizabeth-holmes.htm | title=Blood-Testing Start-Up Theranos Is In 'Pause Period', Says CEO Elizabeth Holmes | publisher=Tech Times | date=22 October 2015 | accessdate=23 October 2016 | author=Derla, Katherine}}</ref><eod>