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FDA Inspection
•Novocure GmbH•April 18, 2024

Novocure GmbH – FDA Inspection, Apr 18, 2024

Record Details

This FDA Inspection record concerns Novocure GmbH, with an inspection on April 18, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Novocure GmbH
Inspection Date
April 18, 2024
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Rosanna M. Goodrich (FDA Associated Person)
View Company Profile

ID · b05f7a61-7f36-4cc0-b0be-a67d29bebb48

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1237850
FDA center
Medical Devices & Rad Health
Project area
Project Evaluation: Devices
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.198(a)Lack of or inadequate complaint procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Novocure GmbH

1
DateClassificationOfficeProject area
December 19, 2025Not classifiedOffice of Inspections and Investigations
Other documents for Novocure GmbH
  • FDA Inspection 1298666 - 2025-12-19

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