Theranos, Inc.
Form 483 issued August 18, 2016 · Palo Alto, California
- Inspection
- Aug 16 – Aug 18, 2016
- Investigators
- Aneel K. Sandhu· Ian A. Pilcher
- Observations
- 1
- Pages
- 1
- FEI number
- 3010479366
In short: On August 18, 2016, FDA issued a Form 483 with 1 observation to Theranos, Inc. in Palo Alto, California (FEI 3010479366) after an inspection that ran Aug 16 – Aug 18, 2016. The investigators were Aneel K. Sandhu and Ian A. Pilcher. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 56.103 (circumstances in which IRB review is required).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 56.103 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Part of an investigation was…
This inspection in context
Aneel K. Sandhu
2 documents · 2006–2016
Cites 56.103 (circumstances in which irb review is required) more than any other section. Most of their documents are for sites in California.
The firmTheranos, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 56.103
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Theranos, Inc.?
FDA listed 1 observation on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 56.103 (circumstances in which IRB review is required). The opening words of each observation are shown on this page.
Who inspected Theranos, Inc.?
Aneel K. Sandhu and Ian A. Pilcher are named on this Form 483, for the inspection of Aug 16 – Aug 18, 2016. Each investigator has a profile showing what they cite most.
When was Theranos, Inc. inspected by FDA?
The inspection ran Aug 16 – Aug 18, 2016, and the Form 483 is dated August 18, 2016.
How do I get the full Form 483 for Theranos, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.