FDA Inspection
Assure Tech (Hangzhou) Co., LtdAssure Tech (Hangzhou) Co., Ltd – FDA Inspection, Nov 21, 2014
Record Details
This FDA Inspection record concerns Assure Tech (Hangzhou) Co., Ltd, with an inspection on November 21, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 21, 2014
- Product Type
- Devices
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ID · f6569ea4-46c8-445a-8542-66295423aebf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 906649
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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Other FDA inspections of Assure Tech (Hangzhou) Co., Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Assure Tech (Hangzhou) Co., Ltd
- FDA Inspection 1078065 - 2018-03-27
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