FDA Inspection
Jiangsu Guangda Medical Material Group Co., Ltd.Jiangsu Guangda Medical Material Group Co., Ltd. – FDA Inspection, Apr 10, 2015
Record Details
This FDA Inspection record concerns Jiangsu Guangda Medical Material Group 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 · edaf6025-a31c-4997-abd5-411be6b9df7a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 926501
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Jiangsu Guangda Medical Material Group Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 31, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 5, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 19, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Jiangsu Guangda Medical Material Group Co., Ltd.
- FDA Inspection 1217706 - 2023-08-31
- FDA Inspection 1081397 - 2018-12-05
- FDA Inspection 802595 - 2012-09-19
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