FDA Inspection
Brigham and Women's HospitalBrigham and Women's Hospital – FDA Inspection, Dec 10, 2015
Record Details
This FDA Inspection record concerns Brigham and Women's Hospital, with an inspection on December 10, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Brigham and Women's Hospital
- Inspection Date
- December 10, 2015
- Product Type
- Devices
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ID · ccdaa98d-a9a9-4fad-b1df-cc08d8bb3808
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953620
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.18(a)Event files -- failure to establish and maintain
- 21 CFR 803.30(a)(2)Report of Serious Injury Within 10 Days
- 21 CFR 803.30(a)(1)Report of Death Within 10 Days
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| September 16, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 22, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1100702 - 2019-08-22
- FDA Inspection 891621 - 2014-08-15
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