FUJIFILM MEDWORK GMBH – FDA Inspection, Mar 26, 2025

Record Details

This FDA Inspection record concerns FUJIFILM MEDWORK GMBH, with an inspection on March 26, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: FUJIFILM MEDWORK GMBH
Inspection Date: March 26, 2025
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Katlin N. Stubbs

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ID · db18885a-bcaa-454e-ac82-d0b181e76b12

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1264887
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction

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FDA Inspection

FUJIFILM MEDWORK GMBHMarch 26, 2025