Pacific Hospital Supply Co., Ltd. FDA Record
Pacific Hospital Supply Co., Ltd. has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 1 compliance action on record. FDA has issued 1 warning letter to Pacific Hospital Supply Co., Ltd., the most recent on May 26, 2017.
- Latest inspection
- Feb 22, 2017 · OAI
- Latest 510(k)
- Jun 29, 2011
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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 | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Pacific Hospital Supply Co., Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| May 26, 2017 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 22, 2017 | Miaoli County, Taiwan | Devices | Official Action Indicated (OAI) | 3014615028 |
| Apr 29, 2015 | Tai Bei Shi, Taiwan | Devices | No Action Indicated (NAI) | 3004458261 |
| Aug 29, 2013 | Miaoli County, Taiwan | Devices | Voluntary Action Indicated (VAI) | 3014615028 |
- 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.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Pacific Hospital Supply Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3014615028 | Miaoli County, Taiwan | 2 | Feb 22, 2017 |
| FEI 3004458261 | Tai Bei Shi, Taiwan | 1 | Apr 29, 2015 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K111672 | MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER | Jun 29, 2011 |
Pacific Hospital Supply Co., Ltd. and the FDA: common questions
Has Pacific Hospital Supply Co., Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Pacific Hospital Supply Co., Ltd.. The most recent is dated May 26, 2017.
Has Pacific Hospital Supply Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Pacific Hospital Supply Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Pacific Hospital Supply Co., Ltd.?
The most recent FDA inspection on file ended Feb 22, 2017 at Miaoli County, Taiwan and was classified OAI. FDA has 3 inspections of Pacific Hospital Supply Co., Ltd. on file, 1 of them classified OAI (official action indicated).
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