Foremount Enterprise Co., Ltd. FDA Record
Foremount Enterprise Co., Ltd. has 0 FDA recalls, 4 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Foremount Enterprise Co., Ltd." is on file. FDA has published 1 Form 483 for Foremount Enterprise Co., Ltd..
- Latest inspection
- Jun 19, 2025 · OAI
- Latest 510(k)
- May 11, 2018
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 | 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
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 1 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Foremount Enterprise Co., Ltd. Form 483s
| Date | Document | FEI |
|---|---|---|
| Jun 19, 2025 | 483 | 3010402691 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 19, 2025 | Tai Zhong Shi, Taiwan | Devices | Official Action Indicated (OAI) | 3010402691 |
| Jan 15, 2020 | Taichung City, Taiwan | Devices | No Action Indicated (NAI) | 3002973578 |
| May 30, 2013 | Taichung City, Taiwan | Devices | Voluntary Action Indicated (VAI) | 3002973578 |
| Jul 29, 2010 | Taichung City, Taiwan | Devices | No Action Indicated (NAI) | 3002973578 |
- 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 3010402691 | Tai Zhong Shi, Taiwan | 1 | Jun 19, 2025 |
| FEI 3002973578 | Taichung City, Taiwan | 3 | Jan 15, 2020 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable… | May 11, 2018 |
Foremount Enterprise Co., Ltd. and the FDA: common questions
Has Foremount Enterprise Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Foremount Enterprise 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 Foremount Enterprise Co., Ltd. received an FDA Form 483?
FDA has published 1 Form 483 for Foremount Enterprise Co., Ltd. in its reading room, the most recent dated Jun 19, 2025. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Foremount Enterprise Co., Ltd.?
The most recent FDA inspection on file ended Jun 19, 2025 at Tai Zhong Shi, Taiwan and was classified OAI. FDA has 4 inspections of Foremount Enterprise Co., Ltd. on file, 1 of them classified OAI (official action indicated).
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