FDA inspection

Fotona d.d.: FDA inspection ending Jun 24, 2004

FDA inspection 336312 · No Action Indicated (NAI) · Ljubljana

Key facts

Inspection ID 336312
Firm Fotona d.d.
FEI number 1000597018
Address Stegne 7
City Ljubljana
Fiscal year 2004
Inspection end date Jun 24, 2004
Classification No Action Indicated (NAI)
Project area Compliance: Med Devices
Product type Devices

At a glance

  • None Citations
  • None 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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