FDA Inspection
Changchun New Industries Optoelectronics Tech. Co., Ltd.Changchun New Industries Optoelectronics Tech. Co., Ltd. – FDA Inspection, May 23, 2011
Record Details
This FDA Inspection record concerns Changchun New Industries Optoelectronics Tech. Co., Ltd., with an inspection on May 23, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 23, 2011
- Product Type
- Devices
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ID · d6c25a83-231d-45eb-8882-cbf931380a7b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 727344
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
6- 21 CFR 1040.10(h)(1)(i)User information, adequate instructions
- 21 CFR 1040.10(f)(6)(i)Beam attenuator
- 21 CFR 1010.3(a)(2)ID label lacks place, month & year of manufacture
- 21 CFR 1005.25(a)Failure to designate US agent for process service
- 21 CFR 1040.10(h)(1)(iii)Legible reproductions
- 21 CFR 1040.10(h)(1)(iv)User info - list controls, etc.
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Other FDA inspections of Changchun New Industries Optoelectronics Tech. Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2009 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Changchun New Industries Optoelectronics Tech. Co., Ltd.
- FDA Inspection 586859 - 2009-04-13
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