FDA Inspection
Kunshan Radiant Innovation Co., LtdKunshan Radiant Innovation Co., Ltd – FDA Inspection, Jan 27, 2015
Record Details
This FDA Inspection record concerns Kunshan Radiant Innovation Co., Ltd, with an inspection on January 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 27, 2015
- Product Type
- Devices
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ID · 883aa343-39bc-4438-8126-05681ab48834
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 916725
- 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 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Kunshan Radiant Innovation Co., Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Kunshan Radiant Innovation Co., Ltd
- FDA Inspection 828893 - 2013-03-29
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