FDA Inspection
Brigham and Women's HospitalBrigham and Women's Hospital – FDA Inspection, Sep 16, 2021
Record Details
This FDA Inspection record concerns Brigham and Women's Hospital, with an inspection on September 16, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Brigham and Women's Hospital
- Inspection Date
- September 16, 2021
- Product Type
- Drugs
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ID · 3b2dc72b-8b2b-49eb-822a-1ef59ebc7679
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1152063
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 212.60(b)Lab sampling and test procedures
- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.30(b)Equipment procedures
- 21 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination
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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 |
| August 22, 2019 | 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 1100702 - 2019-08-22
- FDA Inspection 953620 - 2015-12-10
- FDA Inspection 891621 - 2014-08-15
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