FDA Inspection
Bauerfeind AGBauerfeind AG – FDA Inspection, Feb 8, 2024
Record Details
This FDA Inspection record concerns Bauerfeind AG, with an inspection on February 8, 2024, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 77feb47f-a826-45be-8ca4-ab71a37ffc85
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1228844
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bauerfeind AG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bauerfeind AG
- FDA Inspection 993016 - 2016-11-04
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.