FDA Inspection
Qstar TechnologiesQstar Technologies – FDA Inspection, May 13, 2010
Record Details
This FDA Inspection record concerns Qstar Technologies, with an inspection on May 13, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Qstar Technologies
- Inspection Date
- May 13, 2010
- Product Type
- Devices
View Company Profile
ID · f569f2de-ebbd-4c16-87c8-53f86bc3826d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 662476
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.40(a)Document locations, Dissemination, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 803.17Lack of Written MDR Procedures
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