FDA Inspection
B. Braun Melsungen AGB. Braun Melsungen AG – FDA Inspection, Jun 17, 2011
Record Details
This FDA Inspection record concerns B. Braun Melsungen AG, with an inspection on June 17, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- B. Braun Melsungen AG
- Inspection Date
- June 17, 2011
- Product Type
- Devices
View Company Profile
ID · 41b27373-69af-4b73-a74d-ae75e44d14e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 734877
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
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Other FDA inspections of B. Braun Melsungen AG
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 16, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 19, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for B. Braun Melsungen AG
- FDA Inspection 1009804 - 2017-03-16
- FDA Inspection 914851 - 2015-02-19
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