FDA inspection

Epitope Diagnostics, Inc.: FDA inspection ending Apr 28, 2023

FDA inspection 1203846 · Voluntary Action Indicated (VAI) · San Diego, CA

Key facts

Inspection ID 1203846
Firm Epitope Diagnostics, Inc.
FEI number 3004185580
Address 7110 Carroll Rd
City San Diego
State CA
ZIP 92127
Country United States
Fiscal year 2023
Inspection end date Apr 28, 2023
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
  • No 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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