FDA Inspection
Shenzhen Dongdixin Technology Co., Ltd.Shenzhen Dongdixin Technology Co., Ltd. – FDA Inspection, Sep 7, 2017
Record Details
This FDA Inspection record concerns Shenzhen Dongdixin Technology Co., Ltd., with an inspection on September 7, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- September 7, 2017
- Product Type
- Medical Devices & Rad Health
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ID · e657865e-c41b-4e56-ba5c-e50dafbea1f2
Inspection Facts
- Inspection number
- 1026109
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(e)Documentation
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of Shenzhen Dongdixin Technology Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 16, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Shenzhen Dongdixin Technology Co., Ltd.
- FDA Inspection 873316 - 2014-03-20
- FDA Inspection 705658 - 2010-12-16
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