Theranos, Inc.
Form 483 issued September 16, 2015 · Palo Alto, California
- Inspection
- Aug 25 – Sep 16, 2015
- Investigators
- Ian A. Pilcher· Seema S. Singh
- Observations
- 5
- Pages
- 4
- FEI number
- 3010479366
In short: On September 16, 2015, FDA issued a Form 483 with 5 observations to Theranos, Inc. in Palo Alto, California (FEI 3010479366) after an inspection that ran Aug 25 – Sep 16, 2015. The investigators were Ian A. Pilcher and Seema S. Singh. Most observations concern design controls and records & documents; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
4 of 5 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(g) (3×)
What FDA observed
Preview: the opening words of each observation- 01
Design validation did not ensure the device conforms to defined user…
- 02
The design was not validated under actual…
- 03
Design input requirements were…
- 04
Results of the design risk analysis…
This inspection in context
Ian A. Pilcher
2 documents · 2015–2016
Cites 820.30(c) (design controls) 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 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Theranos, Inc.?
FDA listed 5 observations on this Form 483, mostly about design controls and records & documents. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Theranos, Inc.?
Ian A. Pilcher and Seema S. Singh are named on this Form 483, for the inspection of Aug 25 – Sep 16, 2015. Each investigator has a profile showing what they cite most.
When was Theranos, Inc. inspected by FDA?
The inspection ran Aug 25 – Sep 16, 2015, and the Form 483 is dated September 16, 2015.
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.