FDA inspection

Chembio Diagnostic Systems, Inc: FDA inspection ending Mar 23, 2018

FDA inspection 1045424 · Voluntary Action Indicated (VAI) · Medford, NY

Key facts

Inspection ID 1045424
Firm Chembio Diagnostic Systems, Inc
FEI number 2431980
Address 3661 Horseblock Rd
City Medford
State NY
ZIP 11763
Country United States
Fiscal year 2018
Inspection end date Mar 23, 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
  • 10–99 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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