FUJIFILM Healthcare Manufacturing Corporation Sano Office FDA Record
- Latest inspection VAI · Jan 27, 2023
- No warning letters matched by name
FUJIFILM Healthcare Manufacturing Corporation Sano Office has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "FUJIFILM Healthcare Manufacturing Corporation Sano Office" is on file.
- Latest inspection
- Jan 27, 2023 · VAI
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 | 3 | 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
FUJIFILM Healthcare Manufacturing Corporation Sano Office: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 1 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 27, 2023 | Sano, Japan | Devices | Voluntary Action Indicated (VAI) | 3002808127 |
| Sep 10, 2019 | Sano, Japan | Devices | Official Action Indicated (OAI) | 3002808127 |
| Apr 22, 2015 | Sano, Japan | Devices | No Action Indicated (NAI) | 3002808127 |
- 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 3002808127 | Sano, Japan | 3 | Jan 27, 2023 |
FUJIFILM Healthcare Manufacturing Corporation Sano Office and the FDA: common questions
Has FUJIFILM Healthcare Manufacturing Corporation Sano Office received an FDA warning letter?
No FDA warning letter addressed to the name "FUJIFILM Healthcare Manufacturing Corporation Sano Office" 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 FUJIFILM Healthcare Manufacturing Corporation Sano Office received an FDA Form 483?
FDA has not published a Form 483 for "FUJIFILM Healthcare Manufacturing Corporation Sano Office" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect FUJIFILM Healthcare Manufacturing Corporation Sano Office?
The most recent FDA inspection on file ended Jan 27, 2023 at Sano, Japan and was classified VAI. FDA has 3 inspections of FUJIFILM Healthcare Manufacturing Corporation Sano Office on file, 1 of them classified OAI (official action indicated).
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