FDA inspection

StatSure Diagnostic Systems Inc: FDA inspection ending Jan 12, 2000

FDA inspection 17142 · Official Action Indicated (OAI) · Framingham, MA

Key facts

Inspection ID 17142
Firm StatSure Diagnostic Systems Inc
FEI number 1000126509
Address 1 Clarks Hl
City Framingham
State MA
ZIP 01702-8172
Fiscal year 2000
Inspection end date Jan 12, 2000
Classification Official Action Indicated (OAI)
Project area Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products
Product type Biologics

At a glance

  • None 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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