FDA Inspection
Hebumedical GMBHHebumedical GMBH – FDA Inspection, Jun 2, 2016
Record Details
This FDA Inspection record concerns Hebumedical GMBH, with an inspection on June 2, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hebumedical GMBH
- Inspection Date
- June 2, 2016
- Product Type
- Devices
View Company Profile
ID · 2e3a29b8-804b-4714-ab65-358ad0c934f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 975461
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hebumedical GMBH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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