Rohto Pharmaceutical Co., Ltd. (Ueno Plant) FDA Record
- Latest inspection VAI · Mar 8, 2023
- No warning letters matched by name
Rohto Pharmaceutical Co., Ltd. (Ueno Plant) has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Rohto Pharmaceutical Co., Ltd. (Ueno Plant)" is on file.
- Latest inspection
- Mar 8, 2023 · 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 |
FDA record by year
Rohto Pharmaceutical Co., Ltd. (Ueno Plant): 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 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 8, 2023 | Iga, Japan | Drugs | Voluntary Action Indicated (VAI) | 3003722237 |
| Mar 2, 2018 | Iga, Japan | Drugs | Voluntary Action Indicated (VAI) | 3003722237 |
| Nov 14, 2014 | Iga, Japan | Drugs | Voluntary Action Indicated (VAI) | 3003722237 |
| Nov 20, 2012 | Iga, Japan | Drugs | Voluntary Action Indicated (VAI) | 3003722237 |
- 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 3003722237 | Iga, Japan | 4 | Mar 8, 2023 |
Rohto Pharmaceutical Co., Ltd. (Ueno Plant) and the FDA: common questions
Has Rohto Pharmaceutical Co., Ltd. (Ueno Plant) received an FDA warning letter?
No FDA warning letter addressed to the name "Rohto Pharmaceutical Co., Ltd. (Ueno Plant)" 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 Rohto Pharmaceutical Co., Ltd. (Ueno Plant) received an FDA Form 483?
FDA has not published a Form 483 for "Rohto Pharmaceutical Co., Ltd. (Ueno Plant)" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Rohto Pharmaceutical Co., Ltd. (Ueno Plant)?
The most recent FDA inspection on file ended Mar 8, 2023 at Iga, Japan and was classified VAI. FDA has 4 inspections of Rohto Pharmaceutical Co., Ltd. (Ueno Plant) on file.
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