Brigham And Women's Hospital RDRC FDA Record
- Latest inspection VAI · Sep 19, 2019
- No warning letters matched by name
Brigham And Women's Hospital RDRC has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Brigham And Women's Hospital RDRC" is on file.
- Latest inspection
- Sep 19, 2019 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 19, 2019 | Boston, MA | Drugs | Voluntary Action Indicated (VAI) | 3015196856 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3015196856 | Boston, MA | 1 | Sep 19, 2019 |
Brigham And Women's Hospital RDRC and the FDA: common questions
Has Brigham And Women's Hospital RDRC received an FDA warning letter?
No FDA warning letter addressed to the name "Brigham And Women's Hospital RDRC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Brigham And Women's Hospital RDRC received an FDA Form 483?
FDA has not published a Form 483 for "Brigham And Women's Hospital RDRC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Brigham And Women's Hospital RDRC?
The most recent FDA inspection on file ended Sep 19, 2019 at Boston, MA and was classified VAI. FDA has 1 inspection of Brigham And Women's Hospital RDRC on file.
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