Froedtert Memorial Lutheran Hospital FDA Record
- Latest inspection NAI · Jun 26, 2025
- No warning letters matched by name
Froedtert Memorial Lutheran Hospital has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Froedtert Memorial Lutheran Hospital" is on file.
- Latest inspection
- Jun 26, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 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 |
|---|---|---|---|---|
| Jun 26, 2025 | Milwaukee, WI | Biologics | No Action Indicated (NAI) | 3003981963 |
- 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 3003981963 | Milwaukee, WI | 1 | Jun 26, 2025 |
Froedtert Memorial Lutheran Hospital and the FDA: common questions
Has Froedtert Memorial Lutheran Hospital received an FDA warning letter?
No FDA warning letter addressed to the name "Froedtert Memorial Lutheran Hospital" 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 Froedtert Memorial Lutheran Hospital received an FDA Form 483?
FDA has not published a Form 483 for "Froedtert Memorial Lutheran Hospital" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Froedtert Memorial Lutheran Hospital?
The most recent FDA inspection on file ended Jun 26, 2025 at Milwaukee, WI and was classified NAI. FDA has 1 inspection of Froedtert Memorial Lutheran Hospital on file.
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