FDA Inspection
Shenzhen Dongdixin Technology Co., Ltd.Shenzhen Dongdixin Technology Co., Ltd. – FDA Inspection, Sep 6, 2017
Record Details
This FDA Inspection record concerns Shenzhen Dongdixin Technology Co., Ltd., with an inspection on September 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 464f917e-fd15-4e8d-aaf3-c291a73cfefa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1026108
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.72(b)Remedial action - documentation
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - documentation
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