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# FDA Posts Inspection Report Involving Theranos Test
- URL: https://www.fdaweb.com/fda-posts-inspection-report-involving-theranos-test/
- Published: 2016-09-09T12:00:00.000Z
- Updated: 2026-09-14T21:30:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136762

FDA has posted a one-page [Form-483](http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm519644.pdf?ref=fdaweb.com) from an inspection last month at troubled blood diagnostic firm Theranos, based in Palo Alto, CA. The agency cited the firm for performing clinical investigations prior to obtaining IRB approval. Presumably, the inspection document is related to the company’s decision to withdraw its Zika virus blood test that it had submitted for agency approval ([see story](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=newssearch&cd=2&cad=rja&uact=8&ved=0ahUKEwiOgr2DhYPPAhXE6iYKHcNDAtUQqQIIHigAMAE&url=http%3A%2F%2Fwww.cnn.com%2F2016%2F08%2F31%2Fhealth%2Fzika-theranos-test-withdrawn%2F&usg=AFQjCNH9-EynS5Tb9RANp-Z3xoc9)). “In my mind, this was a positive interaction with the FDA, and I'm grateful for its collaborative approach,” company vice president of regulatory, quality and clinical affairs **Dave Wurtz** said in a statement. “We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency.”