FDA Inspection
CamSight Co IncCamSight Co Inc – FDA Inspection, Nov 26, 2008
Record Details
This FDA Inspection record concerns CamSight Co Inc, with an inspection on November 26, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CamSight Co Inc
- Inspection Date
- November 26, 2008
- Product Type
- Devices
View Company Profile
ID · f9503cd2-8e43-4b45-bfd9-d6254fa7479c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 541044
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.100(b)Procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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