FDA inspection

Southern Implants, (Pty.) Ltd.: FDA inspection ending Oct 7, 2010

FDA inspection 685174 · Official Action Indicated (OAI) · Irene, Gauteng

Key facts

Inspection ID 685174
Firm Southern Implants, (Pty.) Ltd.
FEI number 3003394627
Address One Albert Road
City Irene, Gauteng
Country South Africa
Fiscal year 2011
Inspection end date Oct 7, 2010
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices
Warning letter UCM242940

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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