FDA Inspection 1152063 — Brigham And Women's Hospital, Inc., The
The FDA completed an inspection of Brigham And Women's Hospital, Inc., The on Sep 16, 2021 in Boston, MA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 16, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17763 | 21 CFR 212.20(d) | Determination need for investigation |
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17850 | 21 CFR 212.60(b) | Lab sampling and test procedures |
| 21373 | 21 CFR 212.30(b) | Equipment procedures |
| 21376 | 21 CFR 212.30(a) | Orderly handling, prevention of mix-ups, prevention of contamination |