FDA inspection

Samhall AB: FDA inspection ending Jun 9, 2023

FDA inspection 1208817 · Official Action Indicated (OAI) · Svenstavik

Key facts

Inspection ID 1208817
Firm Samhall AB
FEI number 3002808176
Address Industrivagen 21
City Svenstavik
Country Sweden
Fiscal year 2023
Inspection end date Jun 9, 2023
Classification Official Action Indicated (OAI)
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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