Meriter Health Enterprises FDA Record
Meriter Health Enterprises has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Meriter Health Enterprises" is on file. FDA has published 1 Form 483 for Meriter Health Enterprises.
- Latest inspection
- May 7, 2025 · VAI
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 | 5 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by 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 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Meriter Health Enterprises Form 483s
| Date | Document | FEI |
|---|---|---|
| May 7, 2025 | 483 | 3009166489 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 7, 2025 | Madison, WI | Biologics | Voluntary Action Indicated (VAI) | 3009166489 |
| Feb 10, 2022 | Madison, WI | Biologics | No Action Indicated (NAI) | 3009166489 |
| Oct 31, 2017 | Madison, WI | Biologics | No Action Indicated (NAI) | 3009166489 |
| Dec 18, 2015 | Madison, WI | Biologics | No Action Indicated (NAI) | 3009166489 |
| Nov 12, 2013 | Madison, WI | Biologics | No Action Indicated (NAI) | 3009166489 |
- 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 3009166489 | Madison, WI | 5 | May 7, 2025 |
Meriter Health Enterprises and the FDA: common questions
Has Meriter Health Enterprises received an FDA warning letter?
No FDA warning letter addressed to the name "Meriter Health Enterprises" 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 Meriter Health Enterprises received an FDA Form 483?
FDA has published 1 Form 483 for Meriter Health Enterprises in its reading room, the most recent dated May 7, 2025. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Meriter Health Enterprises?
The most recent FDA inspection on file ended May 7, 2025 at Madison, WI and was classified VAI. FDA has 5 inspections of Meriter Health Enterprises on file.
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