FDA Inspection
CHONGQING ALTRUN BIOLOGICAL TECHNOLOGY DEV.CHONGQING ALTRUN BIOLOGICAL TECHNOLOGY DEV. – FDA Inspection, Aug 12, 2010
Record Details
This FDA Inspection record concerns CHONGQING ALTRUN BIOLOGICAL TECHNOLOGY DEV., with an inspection on August 12, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 12, 2010
- Product Type
- Devices
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ID · b84c4aa4-97bd-4208-b4a1-20b985d181a7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 679359
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of CHONGQING ALTRUN BIOLOGICAL TECHNOLOGY DEV.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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