FDA inspection

Focus Surgery, Inc.: FDA inspection ending Nov 6, 2013

FDA inspection 856776 · Voluntary Action Indicated (VAI) · Indianapolis, IN

Key facts

Inspection ID 856776
Firm Focus Surgery, Inc.
FEI number 3002132857
Address 4000 Pendleton Way
City Indianapolis
State IN
ZIP 46226-5224
Fiscal year 2014
Inspection end date Nov 6, 2013
Classification Voluntary Action Indicated (VAI)
Project area Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical 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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