FDA inspection

Theranos, Inc.: FDA inspection ending Sep 16, 2015

FDA inspection 941546 · Voluntary Action Indicated (VAI) · Palo Alto, CA

Key facts

Inspection ID 941546
Firm Theranos, Inc.
FEI number 3010479366
Address 1701 Page Mill Rd
City Palo Alto
State CA
ZIP 94304
Country United States
Fiscal year 2015
Inspection end date Sep 16, 2015
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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