Gallant Ocean International Inc FDA Record
Gallant Ocean International Inc has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Gallant Ocean International Inc" is on file.
- Latest inspection
- Feb 21, 2023 · VAI
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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 | 3 | 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 | 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 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 21, 2023 | Kaohsiung City, Taiwan | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3008779556 |
| May 13, 2019 | Kaohsiung City, Taiwan | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3008779556 |
| Jul 13, 2012 | Kaohsiung City, Taiwan | Food/Cosmetics | No Action Indicated (NAI) | 3008779556 |
- 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 3008779556 | Kaohsiung City, Taiwan | 3 | Feb 21, 2023 |
Gallant Ocean International Inc and the FDA: common questions
Has Gallant Ocean International Inc received an FDA warning letter?
No FDA warning letter addressed to the name "Gallant Ocean International Inc" 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 Gallant Ocean International Inc received an FDA Form 483?
FDA has not published a Form 483 for "Gallant Ocean International Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Gallant Ocean International Inc?
The most recent FDA inspection on file ended Feb 21, 2023 at Kaohsiung City, Taiwan and was classified VAI. FDA has 3 inspections of Gallant Ocean International Inc on file.
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