FDA Inspection 571626 — ONC Solutions Incorporated
The FDA completed an inspection of ONC Solutions Incorporated on March 23, 2009 in Acton, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 23, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Acton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 2628 | 21 CFR 820.30(e) | Design review procedures - personnel |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |