FDA Inspection
B Braun Medical, Inc.B Braun Medical, Inc. – FDA Inspection, Aug 16, 2012
Record Details
This FDA Inspection record concerns B Braun Medical, Inc., with an inspection on August 16, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- B Braun Medical, Inc.
- Inspection Date
- August 16, 2012
- Product Type
- Devices
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ID · c19bf303-3168-4908-aea3-4e0873823cfd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 794821
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 806.10(d)Notification of extended action
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.180Availability
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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 | |
| October 8, 2010 | 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 681792 - 2010-10-08
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