FDA inspection

Heartsine Technologies Inc: FDA inspection ending Sep 16, 2014

FDA inspection 897171 · Voluntary Action Indicated (VAI) · Newtown, PA

Key facts

Inspection ID 897171
Firm Heartsine Technologies Inc
FEI number 3004018643
Address 121 Friends Ln Ste 400
City Newtown
State PA
ZIP 18940
Country United States
Fiscal year 2014
Inspection end date Sep 16, 2014
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None 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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