FDA Inspection
B. Braun Avitum AGB. Braun Avitum AG – FDA Inspection, Sep 29, 2011
Record Details
This FDA Inspection record concerns B. Braun Avitum AG, with an inspection on September 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- B. Braun Avitum AG
- Inspection Date
- September 29, 2011
- Product Type
- Devices
View Company Profile
ID · 26af4b82-57c8-44ac-835a-277f748a5e9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 749548
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.70(a)Production processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of B. Braun Avitum AG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for B. Braun Avitum AG
- FDA Inspection 631146 - 2009-11-19
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.