FDA inspection

Sensus Healthcare, Inc.: FDA inspection ending Aug 5, 2022

FDA inspection 1177342 · Voluntary Action Indicated (VAI) · Boca Raton, FL

Key facts

Inspection ID 1177342
Firm Sensus Healthcare, Inc.
FEI number 3008513398
Address 851 Broken Sound Pkwy Nw Ste 215
City Boca Raton
State FL
ZIP 33487
Country United States
Fiscal year 2022
Inspection end date Aug 5, 2022
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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