FDA Inspection 638618 — Alcor Scientific, Inc.
The FDA completed an inspection of Alcor Scientific, Inc. on December 31, 2009 in Smithfield, RI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 31, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Smithfield, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2330 | 21 CFR 820.22 | Quality audit corrective action, reaudits {see also 820.100} |
| 2351 | 21 CFR 820.25(b) | Training |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3159 | 21 CFR 820.184 | DHR content |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3370 | 21 CFR 820.198(a)(2) | Oral complaints |
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 537 | 21 CFR 820.70(a) | Production processes |