881180
Advanced Concept Innovations LLC — FEI 3006015326
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 29, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lakeland, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |