FDA Inspection
Colbar Lifescience Ltd.Colbar Lifescience Ltd. – FDA Inspection, Aug 27, 2009
Record Details
This FDA Inspection record concerns Colbar Lifescience Ltd., with an inspection on August 27, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Colbar Lifescience Ltd.
- Inspection Date
- August 27, 2009
- Product Type
- Devices
View Company Profile
ID · 9219f60a-b990-4de0-b41b-a06a001d44e9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 615293
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - documentation
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