FDA inspection

GCE S.R.O.: FDA inspection ending Mar 14, 2024

FDA inspection 1233579 · Voluntary Action Indicated (VAI) · Chotebor

Key facts

Inspection ID 1233579
Firm GCE S.R.O.
FEI number 3003207908
Address Zizkova 381
City Chotebor
Country Czech Republic
Fiscal year 2024
Inspection end date Mar 14, 2024
Classification Voluntary Action Indicated (VAI)
Project area Compliance: 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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