649104
Airpal, Inc. — FEI 2523170
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 2, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Addison, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 4060 | 21 CFR 820.20(b)(3)(i) | Management representative implementing the quality system |
| 4189 | 21 CFR 820.198(a) | General |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |