FDA Inspection
Cobes Industries (Hefei) Co., Ltd.Cobes Industries (Hefei) Co., Ltd. – FDA Inspection, Jul 17, 2014
Record Details
This FDA Inspection record concerns Cobes Industries (Hefei) Co., Ltd., with an inspection on July 17, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 17, 2014
- Product Type
- Devices
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ID · deaff302-0b64-4de4-b517-c45991dc1f3f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 890159
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(d)Personnel requirements, Lack of or inadequate requirements
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Other FDA inspections of Cobes Industries (Hefei) Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2018 | Not classified | Office of Inspections and Investigations | |
| April 28, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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