FDA inspection

MyCardio: FDA inspection ending Jun 26, 2017

FDA inspection 1015573 · Voluntary Action Indicated (VAI) · Denver, CO

Key facts

Inspection ID 1015573
Firm MyCardio
FEI number 3009498109
Address 370 Interlocken Blvd Ste 650
City Denver
State CO
ZIP 80206
Country United States
Fiscal year 2017
Inspection end date Jun 26, 2017
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: 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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