694901
Aero Innovative Research, Inc. (AIR) — FEI 3005837475
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 4, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Valley Center, KS (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3159 | 21 CFR 820.184 | DHR content |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |