FDA Inspection
B Braun Medical, Inc.B Braun Medical, Inc. – FDA Inspection, Oct 8, 2010
Record Details
This FDA Inspection record concerns B Braun Medical, Inc., with an inspection on October 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- B Braun Medical, Inc.
- Inspection Date
- October 8, 2010
- Product Type
- Devices
View Company Profile
ID · 6b3ebd9b-27b1-44df-82fb-d9cebd68e961
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 681792
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(h)Incorrect translation to production specifications
Full citation text and observation details available on the Dashboard.
Other FDA inspections of B Braun Medical, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2018 | Not classified | Dallas District Office | |
| November 16, 2017 | Not classified | Dallas District Office | |
| August 16, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for B Braun Medical, Inc.
- FDA Inspection 1143591 - 2018-08-15
- FDA Inspection 1051945 - 2017-11-16
- FDA Inspection 794821 - 2012-08-16
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