FDA Inspection 782014 — Alcor Scientific, Inc.
The FDA completed an inspection of Alcor Scientific, Inc. on May 9, 2012 in Smithfield, RI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 9, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Smithfield, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3696 | 21 CFR 820.100(b) | Documentation |