FDA Inspection
Wandy Rubber Industrial Co., Ltd.Wandy Rubber Industrial Co., Ltd. – FDA Inspection, Apr 10, 2015
Record Details
This FDA Inspection record concerns Wandy Rubber Industrial Co., Ltd., with an inspection on April 10, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 10, 2015
- Product Type
- Devices
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ID · e46080bd-b0ea-4cb8-afb8-136bec64bf5c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 924031
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Wandy Rubber Industrial Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 21, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Wandy Rubber Industrial Co., Ltd.
- FDA Inspection 1248306 - 2024-08-01
- FDA Inspection 790225 - 2012-06-21
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