FDA Inspection 1100702 — Brigham and Women's Hospital, Inc., The
The FDA completed an inspection of Brigham and Women's Hospital, Inc., The on August 22, 2019 in Boston, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 22, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17759 | 21 CFR 212.20(c) | Adverse effects of changes made |
| 17763 | 21 CFR 212.20(d) | Determination need for investigation |
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17851 | 21 CFR 212.60(c) | Analytical methods |
| 21376 | 21 CFR 212.30(a) | Orderly handling, prevention of mix-ups, prevention of contamination |