FDA Inspection
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. – FDA Inspection, Sep 11, 2025
Record Details
This FDA Inspection record concerns Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., with an inspection on September 11, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- September 11, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 0749aff3-df67-43f3-a557-2722fba2395d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1284280
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 820.80(c)Documentation
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Other FDA inspections of Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 29, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 7, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
- FDA Inspection 1079944 - 2018-11-29
- FDA Inspection 982092 - 2016-04-07
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