752098
Avent, Inc. — FEI 3006646024
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 28, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tucson, AZ (United States)
Citations
| ID | CFR | Description |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3696 | 21 CFR 820.100(b) | Documentation |