Wenzhou Beipu Science & Technology Co., Ltd. FDA Record
Wenzhou Beipu Science & Technology Co., Ltd. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Wenzhou Beipu Science & Technology Co., Ltd." is on file.
- Latest inspection
- Aug 6, 2015 · OAI
- Latest 510(k)
- Feb 25, 2014
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 | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 6, 2015 | Wenzhou, China | Devices | Official Action Indicated (OAI) | 3004496829 |
- 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 3004496829 | Wenzhou, China | 1 | Aug 6, 2015 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K133059 | INSULIN PEN NEEDLE | Feb 25, 2014 |
Wenzhou Beipu Science & Technology Co., Ltd. and the FDA: common questions
Has Wenzhou Beipu Science & Technology Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Wenzhou Beipu Science & Technology 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 Wenzhou Beipu Science & Technology Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Wenzhou Beipu Science & Technology Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Wenzhou Beipu Science & Technology Co., Ltd.?
The most recent FDA inspection on file ended Aug 6, 2015 at Wenzhou, China and was classified OAI. FDA has 1 inspection of Wenzhou Beipu Science & Technology Co., Ltd. on file, 1 of them classified OAI (official action indicated).
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