FDA Inspection 953620 — Brigham And Women's Hospital, Inc., The
The FDA completed an inspection of Brigham And Women's Hospital, Inc., The on Dec 10, 2015 in Boston, MA. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 10, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Boston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 640 | 21 CFR 803.18(a) | Event files -- failure to establish and maintain |
| 656 | 21 CFR 803.30(a)(1) | Report of Death Within 10 Days |
| 658 | 21 CFR 803.30(a)(2) | Report of Serious Injury Within 10 Days |