FDA Inspection
HG Medical GmbhHG Medical Gmbh – FDA Inspection, Jan 9, 2026
Record Details
This FDA Inspection record concerns HG Medical Gmbh, with an inspection on January 9, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · 40f7d072-7022-4fc6-8948-b6ffcd9e7048
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1298508
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.70(g)(3)Adjustment
Full citation text and observation details available on the Dashboard.
Other FDA inspections of HG Medical Gmbh
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for HG Medical Gmbh
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.