FDA Inspection 629332 — Cybernet Medical Corp.
The FDA completed an inspection of Cybernet Medical Corp. on October 30, 2009 in Ann Arbor, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 30, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 4189 | 21 CFR 820.198(a) | General |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |