FDA inspection

Archtek Dental, LLC: FDA inspection ending Jun 2, 2011

FDA inspection 728178 · Official Action Indicated (OAI) · Carmel, IN

Key facts

Inspection ID 728178
Firm Archtek Dental, LLC
FEI number 3000203342
Address 11405 N Pennsylvania St Ste 106
City Carmel
State IN
ZIP 46032
Country United States
Fiscal year 2011
Inspection end date Jun 2, 2011
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • 10–99 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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