FDA inspection

SMK Imaging LLC: FDA inspection ending Apr 15, 2010

FDA inspection 657556 · Voluntary Action Indicated (VAI) · Elmsford, NY

Key facts

Inspection ID 657556
Firm SMK Imaging LLC
FEI number 3010609444
Address 8 Westchester Plz Ste 112 Ste 240
City Elmsford
State NY
ZIP 10523
Country United States
Fiscal year 2010
Inspection end date Apr 15, 2010
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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