FDA Inspection 984345 — B. Braun Medical, Inc.
The FDA completed an inspection of B. Braun Medical, Inc. on Aug 26, 2016 in Allentown, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 26, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Allentown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3696 | 21 CFR 820.100(b) | Documentation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |