FDA inspection

Stryker Craniomaxillofacial Division: FDA inspection ending Dec 10, 2008

FDA inspection 551446 · Official Action Indicated (OAI) · Portage, MI

Key facts

Inspection ID 551446
Firm Stryker Craniomaxillofacial Division
FEI number 3005101424
Address 750 Trade Centre Way Ste 200
City Portage
State MI
ZIP 49002
Country United States
Fiscal year 2009
Inspection end date Dec 10, 2008
Classification Official Action Indicated (OAI)
Project area Postmarket Assurance: Devices
Product type Devices
Warning letter 50519

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • Yes 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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