FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office FDA Record
- Latest inspection OAI · Sep 12, 2019
- No warning letters matched by name
FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya 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 Hitachiomiya Office" is on file.
- Latest inspection
- Sep 12, 2019 · OAI
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 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 12, 2019 | Hitachiomiya, Japan | Devices | Official Action Indicated (OAI) | 3010516924 |
| Apr 20, 2015 | Hitachiomiya, Japan | Devices | No Action Indicated (NAI) | 3010516924 |
| Jan 30, 2014 | Hitachiomiya, Japan | Devices | Voluntary Action Indicated (VAI) | 3010516924 |
- 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 3010516924 | Hitachiomiya, Japan | 3 | Sep 12, 2019 |
FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office and the FDA: common questions
Has FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office received an FDA warning letter?
No FDA warning letter addressed to the name "FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya 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 Hitachiomiya Office received an FDA Form 483?
FDA has not published a Form 483 for "FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office?
The most recent FDA inspection on file ended Sep 12, 2019 at Hitachiomiya, Japan and was classified OAI. FDA has 3 inspections of FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office on file, 1 of them classified OAI (official action indicated).
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