Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. FDA Record
- Latest inspection VAI · Sep 11, 2025
- No warning letters matched by name
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. has 0 FDA recalls, 3 inspections, 12 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd." is on file.
- Latest inspection
- Sep 11, 2025 · VAI
- Latest 510(k)
- Mar 19, 2024
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 12 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 3 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.: FDA inspections per 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 | 0 | 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 |
|---|---|---|---|---|
| Sep 11, 2025 | Taihu, China | Devices | Voluntary Action Indicated (VAI) | 3012116434 |
| Nov 29, 2018 | Taihu, China | Devices | No Action Indicated (NAI) | 3012116434 |
| Apr 7, 2016 | Taihu, China | Devices | No Action Indicated (NAI) | 3012116434 |
- 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 3012116434 | Taihu, China | 3 | Sep 11, 2025 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K234024 | HWJECT Auto-disable syringe | Mar 19, 2024 |
| K230061 | Insulin Syringe | Nov 30, 2023 |
| K230043 | Insulin Pen Needle | Sep 20, 2023 |
| K223323 | Blood Collection Needle (with/without Needle Holder) | Mar 24, 2023 |
| K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle | Nov 4, 2022 |
| K222141 | Safety Blood Collection Needle (Without Needle Holder) | Oct 21, 2022 |
| K220900 | Safety Blood Collection Needles with/without Needle Holder | Aug 10, 2022 |
| K220083 | LDV((Low Dead Volume )Syringe | May 25, 2022 |
| K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set… | Apr 12, 2022 |
| K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe | Oct 18, 2021 |
| K202188 | Safety Blood Collection Sets for Single Use | Feb 19, 2021 |
| K190183 | Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe | Oct 4, 2019 |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. and the FDA: common questions
Has Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Anhui Hongyu Wuzhou Medical Manufacturer 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 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.?
The most recent FDA inspection on file ended Sep 11, 2025 at Taihu, China and was classified VAI. FDA has 3 inspections of Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. on file.
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