Vitalant Magee Women's Hospital Site FDA Record
- Latest inspection NAI · Jul 30, 2025
- No warning letters matched by name
Vitalant Magee Women's Hospital Site has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Vitalant Magee Women's Hospital Site" is on file.
- Latest inspection
- Jul 30, 2025 · NAI
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 | 8 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Vitalant Magee Women's Hospital Site: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 30, 2025 | Pittsburgh, PA | Biologics | No Action Indicated (NAI) | 3004866289 |
| Apr 11, 2023 | Pittsburgh, PA | Biologics | No Action Indicated (NAI) | 3004866289 |
| Jun 10, 2019 | Pittsburgh, PA | Biologics | No Action Indicated (NAI) | 3004866289 |
| Jan 30, 2017 | Pittsburgh, PA | Biologics | Voluntary Action Indicated (VAI) | 3004866289 |
| Jan 28, 2015 | Pittsburgh, PA | Biologics | No Action Indicated (NAI) | 3004866289 |
| Jan 30, 2013 | Pittsburgh, PA | Biologics | No Action Indicated (NAI) | 3004866289 |
| Jan 11, 2011 | Pittsburgh, PA | Biologics | No Action Indicated (NAI) | 3004866289 |
| Feb 18, 2009 | Pittsburgh, PA | Biologics | No Action Indicated (NAI) | 3004866289 |
- 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 3004866289 | Pittsburgh, PA | 8 | Jul 30, 2025 |
Vitalant Magee Women's Hospital Site and the FDA: common questions
Has Vitalant Magee Women's Hospital Site received an FDA warning letter?
No FDA warning letter addressed to the name "Vitalant Magee Women's Hospital Site" 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 Vitalant Magee Women's Hospital Site received an FDA Form 483?
FDA has not published a Form 483 for "Vitalant Magee Women's Hospital Site" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Vitalant Magee Women's Hospital Site?
The most recent FDA inspection on file ended Jul 30, 2025 at Pittsburgh, PA and was classified NAI. FDA has 8 inspections of Vitalant Magee Women's Hospital Site on file.
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