Nipro Medical Industries, Ltd. FDA Record
Nipro Medical Industries, Ltd. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Nipro Medical Industries, Ltd." is on file.
- Latest inspection
- Nov 15, 2018 · 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 | 4 | 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 |
|---|---|---|---|---|
| Nov 15, 2018 | Tatebayashi, Japan | Devices | Voluntary Action Indicated (VAI) | 3002807725 |
| May 15, 2013 | Tatebayashi, Japan | Devices | No Action Indicated (NAI) | 3002807725 |
| Sep 22, 2011 | Tatebayashi, Japan | Devices | No Action Indicated (NAI) | 3002807725 |
| Nov 17, 2009 | Tatebayashi, Japan | Devices | Voluntary Action Indicated (VAI) | 3002807725 |
- 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 3002807725 | Tatebayashi, Japan | 4 | Nov 15, 2018 |
Nipro Medical Industries, Ltd. and the FDA: common questions
Has Nipro Medical Industries, Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Nipro Medical Industries, Ltd." 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 Medical Industries, Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Nipro Medical Industries, Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Nipro Medical Industries, Ltd.?
The most recent FDA inspection on file ended Nov 15, 2018 at Tatebayashi, Japan and was classified VAI. FDA has 4 inspections of Nipro Medical Industries, Ltd. on file.
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