Theranos, Inc.
FDA inspection history in Newark, California, 2015
- 1
- Form 483
Every document, by year
- Form 483
2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Newark, California.
Cited most
Across all Theranos observations on file
- 21 CFR 820.50(a)(1)Purchasing controls2
- 21 CFR 807.20(a)Who must register and submit a device list?1
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.184Device history record1
- 21 CFR 820.198(a)Complaint files1
The complete Theranos file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Newark, California
One Form 483 · 2015 · 9 observations
Latest: Form 483, Sep 16, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-09-16 | 483 Form 483 | Newark, California | 9 | $99 |
Investigators on these documents
FEI number 3006231732 · most recent document Sep 16, 2015
About Theranos, Inc.
How many FDA Form 483s has Theranos, Inc. received?
FDA Intel has 1 Form 483 on file for Theranos, Inc.; the most recent is dated Sep 16, 2015.
When was Theranos, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Theranos, Inc. is a Form 483 dated Sep 16, 2015, for the site in Newark, California.
What did FDA cite at Theranos, Inc.?
The regulations cited most in the observations on file for Theranos, Inc. are 21 CFR 820.50(a)(1) (Purchasing controls), 2 times; 21 CFR 807.20(a) (Who must register and submit a device list?), 1 time; 21 CFR 820.100 (Corrective and preventive action), 1 time.