FDA inspection

Insightra Medical Inc: FDA inspection ending Jan 27, 2025

FDA inspection 1259305 · Official Action Indicated (OAI) · Clarksville, TN

Key facts

Inspection ID 1259305
Firm Insightra Medical Inc
FEI number 3003945344
Address 2543 Madison St Ste 105
City Clarksville
State TN
ZIP 37043
Country United States
Fiscal year 2025
Inspection end date Jan 27, 2025
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices
Warning letter 706921

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • Yes 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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