FDA Inspection 662476 — Qstar Technologies
The FDA completed an inspection of Qstar Technologies on May 13, 2010 in Mary Esther, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 13, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mary Esther, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3200 | 21 CFR 820.40(a) | Document locations, Dissemination, etc. |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |