FDA Inspection
Shenzhen Zifound Infonet Technology Co., Ltd.Shenzhen Zifound Infonet Technology Co., Ltd. – FDA Inspection, Jan 26, 2017
Record Details
This FDA Inspection record concerns Shenzhen Zifound Infonet Technology Co., Ltd., with an inspection on January 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 26, 2017
- Product Type
- Devices
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ID · b26bf43c-91ad-4b23-80da-45e4d04e4148
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003123
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
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Other FDA inspections of Shenzhen Zifound Infonet Technology Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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