FDA inspection

Mako Surgical Corporation: FDA inspection ending Aug 11, 2014

FDA inspection 891655 · Voluntary Action Indicated (VAI) · Weston, FL

Key facts

Inspection ID 891655
Firm Mako Surgical Corporation
FEI number 3005985723
Address 3365 Enterprise Ave
City Weston
State FL
ZIP 33331
Country United States
Fiscal year 2014
Inspection end date Aug 11, 2014
Classification Voluntary Action Indicated (VAI)
Project area Compliance: 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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