FDA Inspection
Cobes Industries (Hefei) Co., Ltd.Cobes Industries (Hefei) Co., Ltd. – FDA Inspection, Apr 28, 2011
Record Details
This FDA Inspection record concerns Cobes Industries (Hefei) Co., Ltd., with an inspection on April 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 28, 2011
- Product Type
- Devices
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ID · 120871dd-92ad-44c4-a95a-8dd6d32c3a46
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 730180
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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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 | |
| July 17, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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