FDA Inspection
Alere (Shanghai) Diagnostics Co., Ltd.Alere (Shanghai) Diagnostics Co., Ltd. – FDA Inspection, Dec 2, 2010
Record Details
This FDA Inspection record concerns Alere (Shanghai) Diagnostics Co., Ltd., with an inspection on December 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 2, 2010
- Product Type
- Devices
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ID · 4cd1480a-6a3f-4f67-90a6-8b6b58fa4728
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 706893
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
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Other FDA inspections of Alere (Shanghai) Diagnostics Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 25, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 14, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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