FDA inspection

Orbis Medical Inc: FDA inspection ending Jan 23, 2015

FDA inspection 912436 · Voluntary Action Indicated (VAI) · Palmetto Bay, FL

Key facts

Inspection ID 912436
Firm Orbis Medical Inc
FEI number 3010131978
Address 17125 SW 81st Ct
City Palmetto Bay
State FL
ZIP 33157
Country United States
Fiscal year 2015
Inspection end date Jan 23, 2015
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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