FDA Inspection
Hubei Weikang Protective Products Co., Ltd.Hubei Weikang Protective Products Co., Ltd. – FDA Inspection, Oct 30, 2019
Record Details
This FDA Inspection record concerns Hubei Weikang Protective Products Co., Ltd., with an inspection on October 30, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 30, 2019
- Product Type
- Devices
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ID · 9e2f253e-4799-46d6-9c2e-4c963ded5c26
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1108576
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Hubei Weikang Protective Products Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 4, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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