FDA Inspection 718263 — Alcor Scientific, Inc.
The FDA completed an inspection of Alcor Scientific, Inc. on March 30, 2011 in Smithfield, RI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 30, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Smithfield, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |