St. Joseph Healthcare St Joseph Hospital FDA Record
- Latest inspection NAI · Mar 14, 2025
- No warning letters matched by name
St. Joseph Healthcare St Joseph Hospital has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "St. Joseph Healthcare St Joseph Hospital" is on file.
- Latest inspection
- Mar 14, 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 | 7 | 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
St. Joseph Healthcare St Joseph Hospital: 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 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 14, 2025 | Bangor, ME | Biologics | No Action Indicated (NAI) | 1273070 |
| Jul 1, 2022 | Bangor, ME | Biologics | No Action Indicated (NAI) | 1273070 |
| Dec 6, 2018 | Bangor, ME | Biologics | Voluntary Action Indicated (VAI) | 1273070 |
| Mar 24, 2017 | Bangor, ME | Biologics | No Action Indicated (NAI) | 1273070 |
| Oct 28, 2014 | Bangor, ME | Biologics | No Action Indicated (NAI) | 1273070 |
| Mar 29, 2011 | Bangor, ME | Biologics | No Action Indicated (NAI) | 1273070 |
| Jan 27, 2010 | Bangor, ME | Biologics | No Action Indicated (NAI) | 1273070 |
- 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 1273070 | Bangor, ME | 7 | Mar 14, 2025 |
St. Joseph Healthcare St Joseph Hospital and the FDA: common questions
Has St. Joseph Healthcare St Joseph Hospital received an FDA warning letter?
No FDA warning letter addressed to the name "St. Joseph Healthcare St Joseph 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 St. Joseph Healthcare St Joseph Hospital received an FDA Form 483?
FDA has not published a Form 483 for "St. Joseph Healthcare St Joseph Hospital" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect St. Joseph Healthcare St Joseph Hospital?
The most recent FDA inspection on file ended Mar 14, 2025 at Bangor, ME and was classified NAI. FDA has 7 inspections of St. Joseph Healthcare St Joseph Hospital on file.
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