Primo Medical Group FDA Record
Primo Medical Group has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Primo Medical Group" is on file.
- Latest inspection
- Mar 11, 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 | 8 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 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 |
|---|---|---|---|---|
| Mar 11, 2025 | West Bridgewater, MA | Devices | No Action Indicated (NAI) | 3009420598 |
| Sep 17, 2021 | West Bridgewater, MA | Devices | No Action Indicated (NAI) | 3009420598 |
| Oct 3, 2019 | Stoughton, MA | Devices | No Action Indicated (NAI) | 1000120613 |
| Apr 24, 2017 | West Bridgewater, MA | Devices | No Action Indicated (NAI) | 3009420598 |
| Jul 27, 2015 | Stoughton, MA | Devices | Voluntary Action Indicated (VAI) | 1000120613 |
| Dec 10, 2012 | West Bridgewater, MA | Devices | Voluntary Action Indicated (VAI) | 3009420598 |
| Feb 18, 2011 | Stoughton, MA | Devices | Voluntary Action Indicated (VAI) | 1000120613 |
| Nov 6, 2009 | Stoughton, MA | Devices | No Action Indicated (NAI) | 1000120613 |
- 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 3009420598 | West Bridgewater, MA | 4 | Mar 11, 2025 |
| FEI 1000120613 | Stoughton, MA | 4 | Oct 3, 2019 |
Primo Medical Group and the FDA: common questions
Has Primo Medical Group received an FDA warning letter?
No FDA warning letter addressed to the name "Primo Medical Group" 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 Primo Medical Group received an FDA Form 483?
FDA has not published a Form 483 for "Primo Medical Group" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Primo Medical Group?
The most recent FDA inspection on file ended Mar 11, 2025 at West Bridgewater, MA and was classified NAI. FDA has 8 inspections of Primo Medical Group on file.
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