Company
GermanyB. Braun Melsungen AG, Melsungen, Germany – FDA Inspections
Inspection records and compliance data for B. Braun Melsungen AG in Melsungen. 3 FDA inspections on record, last inspected March 16, 2017.
Company Profile
This profile covers B. Braun Melsungen AG based in Melsungen, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 17, 2011. Last inspected March 16, 2017.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design review - Lack of or inadequate procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 16, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1009804 |
| February 19, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 914851 |
| June 17, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 734877 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
B. Braun Melsungen AG
FEI Number
3002806469
Address
Carl-Braun-Str. 1, Melsungen, Germany
Country
Germany
ID: d9ef097b-41b9-4a43-8cfc-8fb55e957996