FDA Inspection
Brigham and Women's HospitalBrigham and Women's Hospital – FDA Inspection, Aug 22, 2019
Record Details
This FDA Inspection record concerns Brigham and Women's Hospital, with an inspection on August 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 3d543564-3332-4b03-b996-ace6919b1b79
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1100702
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.20(c)Adverse effects of changes made
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination
- 21 CFR 212.60(c)Analytical methods
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Brigham and Women's Hospital
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 22, 2026 | Not classified | New England District Office | Drug Quality Assurance |
| April 11, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 16, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 10, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 15, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Brigham and Women's Hospital
- FDA Inspection 1323146 - 2026-06-22
- FDA Inspection 1203279 - 2023-04-11
- FDA Inspection 1152063 - 2021-09-16
- FDA Inspection 953620 - 2015-12-10
- FDA Inspection 891621 - 2014-08-15
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.