Theranos, Inc.
Form 483 issued September 16, 2015 · Newark, California
- Inspection
- Aug 25 – Sep 16, 2015
- Investigators
- Mary R. Hole· Stayce E. Beck· Yung W. Chan
- Observations
- 9
- Pages
- 6
- FEI number
- 3006231732
In short: On September 16, 2015, FDA issued a Form 483 with 9 observations to Theranos, Inc. in Newark, California (FEI 3006231732) after an inspection that ran Aug 25 – Sep 16, 2015. The investigators were Mary R. Hole, Stayce E. Beck and Yung W. Chan. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
Production & process controls and capa account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 807.20(a)
Devices for which listing is required…
- 02
Observation 2: scanned text, readable in the full document.
- 04
Observation 4: scanned text, readable in the full document.
- 05
Software validation activities and results fur computers or automated data processing systems used as part ofproduction…
This inspection in context
Mary R. Hole
7 documents · 2013–2017
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmTheranos, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Theranos, Inc.?
FDA listed 9 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected Theranos, Inc.?
Mary R. Hole, Stayce E. Beck and Yung W. Chan 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.