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FDA Inspection
•Freudenberg Medical Europe GmbH•October 30, 2025

Freudenberg Medical Europe GmbH – FDA Inspection, Oct 30, 2025

Record Details

This FDA Inspection record concerns Freudenberg Medical Europe GmbH, with an inspection on October 30, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Freudenberg Medical Europe GmbH
Inspection Date
October 30, 2025
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • John A. Sciacchitano (Company Rep)
View Company Profile

ID · cfe53d24-9d33-460b-833b-3aeb0ed59a31

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1289226
FDA center
Medical Devices & Rad Health
Project area
Product Evaluation: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

2
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

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