Infus Medical (Thailand) Co., Ltd. FDA Record
Infus Medical (Thailand) Co., Ltd. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Infus Medical (Thailand) Co., Ltd." is on file.
- Latest inspection
- Mar 12, 2025 · NAI
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 | 5 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 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 12, 2025 | Preaksa, Thailand | Devices | No Action Indicated (NAI) | 1000434163 |
| Sep 15, 2022 | Preaksa, Thailand | Devices | No Action Indicated (NAI) | 1000434163 |
| Sep 5, 2018 | Preaksa, Thailand | Devices | No Action Indicated (NAI) | 1000434163 |
| Oct 2, 2014 | Preaksa, Thailand | Devices | No Action Indicated (NAI) | 1000434163 |
| Aug 25, 2011 | Preaksa, Thailand | Devices | No Action Indicated (NAI) | 1000434163 |
- 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 1000434163 | Preaksa, Thailand | 5 | Mar 12, 2025 |
Infus Medical (Thailand) Co., Ltd. and the FDA: common questions
Has Infus Medical (Thailand) Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Infus Medical (Thailand) 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 Infus Medical (Thailand) Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Infus Medical (Thailand) Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Infus Medical (Thailand) Co., Ltd.?
The most recent FDA inspection on file ended Mar 12, 2025 at Preaksa, Thailand and was classified NAI. FDA has 5 inspections of Infus Medical (Thailand) Co., Ltd. on file.
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