Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. FDA Record
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. has 4 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd." is on file. FDA has published 1 Form 483 for Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd..
- Latest recall
- D-0466-2024 · Class III · Apr 9, 2024
- Latest inspection
- Mar 22, 2024 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 4 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 4 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. Form 483s
| Date | Document | FEI |
|---|---|---|
| Mar 22, 2024 · Document on fda.gov | 483 | 3002807834 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0466-2024 | Class III | Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America… | Apr 9, 2024 |
| D-0468-2024 | Class III | Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America… | Apr 9, 2024 |
| D-0467-2024 | Class III | Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7… | Apr 9, 2024 |
| D-0469-2024 | Class III | Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America… | Apr 9, 2024 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 22, 2024 | Tokushima, Japan | Drugs | Voluntary Action Indicated (VAI) | 3002807834 |
| Sep 10, 2019 | Tokushima, Japan | Drugs | Voluntary Action Indicated (VAI) | 3002807834 |
| Mar 23, 2018 | Tokushima, Japan | Drugs | Voluntary Action Indicated (VAI) | 3002807834 |
| Feb 12, 2016 | Tokushima, Japan | Devices | Voluntary Action Indicated (VAI) | 3002807834 |
| Jun 26, 2014 | Tokushima, Japan | Drugs | Voluntary Action Indicated (VAI) | 3002807834 |
| Jul 9, 2012 | Tokushima, Japan | Drugs | Voluntary Action Indicated (VAI) | 3002807834 |
| Oct 27, 2011 | Tokushima, Japan | Drugs | Voluntary Action Indicated (VAI) | 3002807834 |
- 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 3002807834 | Tokushima, Japan | 7 | Mar 22, 2024 |
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. and the FDA: common questions
Has Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Second Tokushima Factory, Otsuka Pharmaceutical Co., 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 Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. received an FDA Form 483?
FDA has published 1 Form 483 for Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. in its reading room, the most recent dated Mar 22, 2024. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.?
The most recent FDA inspection on file ended Mar 22, 2024 at Tokushima, Japan and was classified VAI. FDA has 7 inspections of Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. on file.
Has Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. had an FDA recall?
Yes. Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. has 4 FDA recalls on record. The most recent started Apr 9, 2024.
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