FDA inspection

Swiss Bionic Solutions GmbH: FDA inspection ending Sep 28, 2023

FDA inspection 1220425 · Official Action Indicated (OAI) · Schindellegi

Key facts

Inspection ID 1220425
Firm Swiss Bionic Solutions GmbH
FEI number 3007791564
Address Schulhausstrasse 17
City Schindellegi
Country Switzerland
Fiscal year 2023
Inspection end date Sep 28, 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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