FDA Inspection
Koo Medical Equipment (Shanghai) Co., Ltd.Koo Medical Equipment (Shanghai) Co., Ltd. – FDA Inspection, Sep 12, 2013
Record Details
This FDA Inspection record concerns Koo Medical Equipment (Shanghai) Co., Ltd., with an inspection on September 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 12, 2013
- Product Type
- Devices
View Company Profile
ID · 886e8e8b-22b8-40e0-9835-0cf11e03abce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 850439
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Koo Medical Equipment (Shanghai) Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Koo Medical Equipment (Shanghai) Co., Ltd.
- FDA Inspection 753820 - 2011-10-26
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