FDA Inspection
Carclo Technical Plastics Shanghai Co., Ltd.Carclo Technical Plastics Shanghai Co., Ltd. – FDA Inspection, Apr 22, 2010
Record Details
This FDA Inspection record concerns Carclo Technical Plastics Shanghai Co., Ltd., with an inspection on April 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 22, 2010
- Product Type
- Devices
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ID · d9981dac-1775-4e5b-8aba-05fc5f62f9b7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 659705
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.90(a)Specific non-conforming product procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.180Legibility
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Other FDA inspections of Carclo Technical Plastics Shanghai Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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