1167084
Aggredyne, Inc. — FEI 3009610394
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |