FDA Inspection
AZ Instrument (Shen Zhen) Co., Ltd.AZ Instrument (Shen Zhen) Co., Ltd. – FDA Inspection, Nov 11, 2010
Record Details
This FDA Inspection record concerns AZ Instrument (Shen Zhen) Co., Ltd., with an inspection on November 11, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 11, 2010
- Product Type
- Devices
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ID · 56520099-e9e0-4227-abcf-6c0be04d12dd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 704298
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of AZ Instrument (Shen Zhen) Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for AZ Instrument (Shen Zhen) Co., Ltd.
- FDA Inspection 891964 - 2014-07-16
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