FDA inspection

Biocare Systems, Inc.: FDA inspection ending Dec 3, 2010

FDA inspection 701319 · Voluntary Action Indicated (VAI) · Parker, CO

Key facts

Inspection ID 701319
Firm Biocare Systems, Inc.
FEI number 3005510978
Address 10940 S Parker Rd Pmb 107
City Parker
State CO
ZIP 80134
Country United States
Fiscal year 2011
Inspection end date Dec 3, 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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