FDA inspection

Greenwald Surgical Company, Inc.: FDA inspection ending Mar 15, 2018

FDA inspection 1044946 · Voluntary Action Indicated (VAI) · Lake Station, IN

Key facts

Inspection ID 1044946
Firm Greenwald Surgical Company, Inc.
FEI number 1818662
Address 2688 Dekalb St
City Lake Station
State IN
ZIP 46405
Country United States
Fiscal year 2018
Inspection end date Mar 15, 2018
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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