Theranos, Inc.
FDA inspection history in Palo Alto, California, 2015 to 2016
- 2
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–16Two Form 483s, at Palo Alto, California.
- 2015The longest 483 on file: 5 observations over 4 pages at Palo Alto, California.
Cited most
Across all Theranos observations on file
- 21 CFR 820.30(c)Design controls4
- 21 CFR 56.103Circumstances in which IRB review is required1
- 21 CFR 820.40(a)Document controls1
The complete Theranos file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Palo Alto, California
Two Form 483s · 2015 to 2016 · 6 observations
Latest: Form 483, Aug 18, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-08-18 | 483 Form 483 | Palo Alto, California | 1 | $99 |
| 2015-09-16 | 483 Form 483 | Palo Alto, California | 5 | $99 |
Investigators on these documents
FEI number 3010479366 · most recent document Aug 18, 2016
About Theranos, Inc.
How many FDA Form 483s has Theranos, Inc. received?
FDA Intel has 2 Form 483s on file for Theranos, Inc.; the most recent is dated Aug 18, 2016.
When was Theranos, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Theranos, Inc. is a Form 483 dated Aug 18, 2016, for the site in Palo Alto, California.
What did FDA cite at Theranos, Inc.?
The regulations cited most in the observations on file for Theranos, Inc. are 21 CFR 820.30(c) (Design controls), 4 times; 21 CFR 56.103 (Circumstances in which IRB review is required), 1 time; 21 CFR 820.40(a) (Document controls), 1 time.