FDA Inspection 794821 — B Braun Medical, Inc.
The FDA completed an inspection of B Braun Medical, Inc. on August 16, 2012 in Carrollton, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 16, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Carrollton, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 4207 | 21 CFR 806.10(d) | Notification of extended action |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |