Nipro Vascular Innovations Americas Inc FDA Record
Nipro Vascular Innovations Americas Inc has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Nipro Vascular Innovations Americas Inc" is on file.
- Latest inspection
- Mar 4, 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 | 7 | 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 | 1 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
Reviewing Nipro Vascular Innovations Americas Inc as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Nipro Vascular Innovations Americas Inc yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 4, 2025 | Bedford, MA | Devices | No Action Indicated (NAI) | 3015551113 |
| Jan 9, 2024 | Bedford, MA | Devices | No Action Indicated (NAI) | 3015551113 |
| Dec 8, 2021 | Bedford, MA | Devices | No Action Indicated (NAI) | 3015551113 |
| Jun 2, 2017 | Bedford, MA | Devices | No Action Indicated (NAI) | 3015551113 |
| Apr 10, 2015 | Bedford, MA | Devices | No Action Indicated (NAI) | 3015551113 |
| Nov 15, 2012 | Bedford, MA | Devices | Voluntary Action Indicated (VAI) | 3015551113 |
| Oct 29, 2009 | Bedford, MA | Devices | No Action Indicated (NAI) | 3015551113 |
- 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 3015551113 | Bedford, MA | 7 | Mar 4, 2025 |
Nipro Vascular Innovations Americas Inc and the FDA: common questions
Has Nipro Vascular Innovations Americas Inc received an FDA warning letter?
No FDA warning letter addressed to the name "Nipro Vascular Innovations Americas Inc" 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 Nipro Vascular Innovations Americas Inc received an FDA Form 483?
FDA has not published a Form 483 for "Nipro Vascular Innovations Americas Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Nipro Vascular Innovations Americas Inc?
The most recent FDA inspection on file ended Mar 4, 2025 at Bedford, MA and was classified NAI. FDA has 7 inspections of Nipro Vascular Innovations Americas Inc on file.
Need more than this page shows? Ask about Nipro Vascular Innovations Americas Inc in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.