Thai Hospital Products Co., Ltd. FDA Record
- Latest inspection VAI · Jun 22, 2023
- No warning letters matched by name
Thai Hospital Products Co., Ltd. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Thai Hospital Products Co., Ltd." is on file.
- Latest inspection
- Jun 22, 2023 · VAI
- Latest 510(k)
- Aug 29, 1991
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | 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
Thai Hospital Products Co., Ltd.: 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 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 22, 2023 | Pakkret, Thailand | Devices | Voluntary Action Indicated (VAI) | 3003024808 |
| Jan 26, 2017 | Pakkret, Thailand | Devices | No Action Indicated (NAI) | 3003024808 |
- 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 3003024808 | Pakkret, Thailand | 2 | Jun 22, 2023 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K911334 | MASK, SURGICAL APPAREL | Aug 29, 1991 |
Thai Hospital Products Co., Ltd. and the FDA: common questions
Has Thai Hospital Products Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Thai Hospital Products 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 Thai Hospital Products Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Thai Hospital Products Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Thai Hospital Products Co., Ltd.?
The most recent FDA inspection on file ended Jun 22, 2023 at Pakkret, Thailand and was classified VAI. FDA has 2 inspections of Thai Hospital Products Co., Ltd. on file.
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