FDA Inspection 640530 — Arteriocyte Medical Systems Inc
The FDA completed an inspection of Arteriocyte Medical Systems Inc on January 25, 2010 in Hopkinton, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 25, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hopkinton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2338 | 21 CFR 820.22 | Quality audit - audit report review |
| 3299 | 21 CFR 820.100(a)(1) | Procedure for analysis of data sources |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |